MICRUSFRAME18 20MM X 50CM
Report
- Report Number
- 3008114965-2018-00510
- Event Type
- Malfunction
- Date Received
- January 25, 2018
- Date of Event
- December 13, 2017
- Report Date
- December 13, 2017
- Manufacturer
- REFER TO SECTION H10
- Product Code
- KRD
- UDI-DI
- 10886704078173
- PMA / PMN Number
- K150319
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION RECEIVED INDICATED THAT EXCESSIVE FORCE WAS NOT APPLIED AT ANY TIME DURING THE PROCEDURE. NO RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE MICRUSFRAME18 COIL DELIVERY SYSTEM INTO THE MICROCATHETER. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. NO FURTHER INFORMATION WAS PROVIDED. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RENAL ARTERY ANEURYSM, A 24 MM X 60 CM DELTAFILL18 THERMO-MECHANICAL COIL (DLF182460/S13373) WAS FLUSHED AND INSERTED INTO THE 150/5 CM 45TIP PROWLER SELECT PLUS MICROCATHETER (606-S255FX/17665864); HOWEVER, RESISTANCE WAS FELT AT THE MID-PORTION OF THE MICROCATHETER. THE COIL DELIVERY SYSTEM WAS REMOVED AND FLUSHING LEVEL WAS INCREASED. AFTER THE MICROCATHETER WAS FLUSHED, THE COIL DELIVERY SYSTEM WAS RE-INSERTED BUT STRONG RESISTANCE WAS STILL FELT AT THE MID-PORTION OF THE MICROCATHETER. THE COIL COULD NOT BE RETRACTED; THEREFORE, THE COIL AND THE MICROCATHETER WERE REMOVED AS A UNIT. THE PROWLER SELECT PLUS MICROCATHETER WAS REPLACED WITH A COMPETITOR PRODUCT AND THE COIL WAS REPLACED WITH A 20 MM X 50 CM MICRUSFRAMEE18 (MFR182050/S14024) THERMO-MECHANICAL COIL. THE PHYSICIAN ATTEMPTED TO INSERT THE MICRUSFRAME18 COIL DELIVERY SYSTEM, BUT THE SHEATH SLIT AND THE PRODUCT COULD NOT BE USED. THE COIL WAS SUBSEQUENTLY REPLACED. A TOTAL OF 20 DELTAFILL COILS WERE IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S VESSEL WAS MILDLY TORTUOUS AND NOT CALCIFIED. A DCB02 DETACHMENT CONTROL BOX, AN EXCELSIOR 1018 (STRYKER), A 4F SHEATHLESSPV (ASAHI INTECC) GUIDING CATHETER, A Y-CONNECTOR (TERUMO), AND AN ENPOWER CONTROL CABLE WERE ALSO USED FOR THE CASE. AN ANGIOCATHETER WAS INSERTED INTO THE GUIDING SHEATH. THE PROWLER SELECT PLUS MICROCATHETER WAS THEN INSERTED TO INITIATE COILING. THE MICROCATHETER WAS PLACED IN THE ANEURYSM AND A 20MM MICRUSFRAME COIL WAS INSERTED. HOWEVER, IT WAS UNDERSIZED AND REMOVED FROM THE PATIENT. THE DELTAFILL18 COIL WAS THEN PREPARED FOR USE. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT EXCESSIVE FORCE WAS NOT APPLIED AT ANY TIME DURING THE PROCEDURE. NO RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE MICRUSFRAME18 COIL DELIVERY SYSTEM INTO THE MICROCATHETER. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. NO FURTHER INFORMATION WAS PROVIDED. THE DELTAFILL18 24MM X 60CM/LOT # S13373 WAS RETURNED IN TWO PIECES UNDER SEPARATE COVER. ONE PIECE CONSISTED OF THE STRETCHED EMBOLIC COIL AND THE DISTAL PORTION OF THE DEVICE POSITIONING UNIT (DPU). THE DISTAL END OF THE EMBOLIC COIL WAS ANCHORED IN THE PROWLER SELECT PLUS MICROCATHETER DOCUMENTED IN THE COMPLAINT. THE TIP COIL WAS SEVERELY BENT. THE DPU CORE WIRE HAD BEEN SEVERED. THE SECOND PIECE CONSISTED OF THE REMAINDER OF THE DPU AND THE INTRODUCER. THERE WAS A SMALL AMOUNT OF BLOOD IN THE TRANSLUCENT INTRODUCER SHEATH. THE SEVERED END OF THE DPU CORE WIRE WAS ADVANCED OUT OF THE GREEN INTRODUCER. THERE WAS A BEND IN THE DPU CORE WIRE APPROXIMATELY 73 CM FROM THE PROXIMAL END. THERE WAS SOME MATERIAL, POSSIBLY BLOOD, DEPOSITED ON THE RESHEATHING TOOL. THE V-NOTCH WAS UNDAMAGED. THE DISTAL END OF THE EMBOLIC COIL WAS ANCHORED IN THE MICROCATHETER AND COULD NOT BE VISUALIZED. THE EMBOLIC COIL WAS SEVERELY STRETCHED AND TANGLED. THE ARTICULATING JOINT WAS COMPRESSED. THE RESISTANCE HEATING (RH) COIL HAD NOT BEEN HEATED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE NON-STERILE PROWLER SEL PLUS 150/5CM 45TIP/LOT # 17665864 MICROCATHETER WAS RECEIVED COILED INSIDE OF A POUCH. THE RECEIVED PRODUCT WAS INSPECTED AND FOUND KINKED AT 65CM FROM THE PROXIMAL END OF THE HUB. AN EMBOLIC COIL WAS FOUND STUCK INSIDE OF IT. THE RECEIVED MICROCATHETER WAS INSPECTED UNDER MICROSCOPE AND NOTED TO BE KINKED. THE INTERNAL DIAMETER (ID) OF THE MICROCATHETER WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE EMBOLIC COIL WAS REMOVED FROM THE RECEIVED MICROCATHETER AND DRIED BLOOD RESIDUE WAS OBSERVED ON THE COIL. AN .018 GUIDEWIRE LAB SAMPLE WAS INTRODUCED INTO THE RECEIVED MICROCATHETER BUT IT COULD NOT PASS THROUGH. THE MICROCATHETER WAS CUT AT 14CM FROM THE DISTAL END AND THE GUIDEWIRE WAS RE-INSERTED. RESISTANCE/FRICTION WAS FELT WHEN IT WAS ADVANCED THROUGH THE MICROCATHETER. ADDITIONAL FORCE WAS APPLIED TO THE GUIDEWIRE AND THE DRIED BLOOD RESIDUE CAME OUT FROM THE CUT SECTION OF THE MICROCATHETER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT REVEALED THAT 11 UNITS WERE REJECTED DUE TO SCRUNCH DEFECT AND A SCRUNCH DEFECT COULD BE RELATED TO THE REPORTED COMPLAINT. HOWEVER, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE MICRUSFRAME18 20MM X 50CM/LOT # S14024 WAS RETURNED INSERTED THROUGH A CONCOMITANT DEVICE, MOST LIKELY THE GUIDING SHEATH REFERENCED IN THE COMPLAINT. THE CONCOMITANT DEVICE WAS BLUE AND SLIT LENGTHWISE. THE EMBOLIC COIL PROTRUDED THROUGH THE SLIT IN THE CONCOMITANT DEVICE. PART OF THE DISTAL END OF THE DEVICE POSITIONING UNIT (DPU) EXITED THE CONCOMITANT DEVICE, FOLDED OVER, AND RE-ENTERED IT. THE RESHEATHING TOOL WAS BROKEN. THE DISTAL END OF THE RESHEATHING TOOL WAS EMBEDDED IN THE PROXIMAL END OF THE CONCOMITANT DEVICE. THERE WAS BLOOD THROUGHOUT THE TRANSLUCENT INTRODUCER SHEATH. THERE WERE BENDS IN THE DPU CORE WIRE APPROXIMATELY 7 CM AND 157 CM FROM THE PROXIMAL END. THE BALL TIP WAS INTACT. THERE WAS BLOOD ON THE EMBOLIC COIL. THE EMBOLIC COIL PROTRUDED FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. THE EMBOLIC COIL PASSED INTO THE CONCOMITANT DEVICE, THE EXTENDED COIL EXITED, THEN BENDED OVER, AND THE DPU CORE WIRE RE-ENTERED THE DEVICE. THE MARKER BAND WAS KINKED. THE EMBOLIC COIL THAT PROTRUDED FROM THE SLIT IN THE CONCOMITANT DEVICE WAS STRETCHED. THE ARTICULATING JOINT WAS INTACT. THE RESISTANCE HEATING (RH) COIL WAS INSIDE THE CONCOMITANT DEVICE AND COULD NOT BE OBSERVED. WHILE THE RESHEATHING TOOL WAS BROKEN, THE V-NOTCH WAS UNDAMAGED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT THAT THE DELTAFILL18 24MM X 60CM/LOT # S13373 WAS IMPEDED IN THE MICROCATHETER WAS CONFIRMED. THE DEVICE WAS ANCHORED IN THE MICROCATHETER AND COULD NOT BE ADVANCED OR RETRACTED. THE BEND IN THE DPU CORE WIRE AND THE DAMAGE TO THE ARTICULATING JOINT ARE EVIDENCE THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE, POSSIBLY IN AN ATTEMPT TO OVERCOME THE REPORTED RESISTANCE IN THE MICROCATHETER. THE SEVERE STRETCHING OF THE EMBOLIC COIL IS MOST LIKELY A RESULT OF APPLICATION OF EXCESSIVE FORCE IN AN ATTEMPT TO REMOVE THE DEVICE FROM THE MICROCATHETER. THE BLOOD ON THE RESHEATHING TOOL AND IN THE TRANSLUCENT INTRODUCER SHEATH MAY INDICATE THAT INSUFFICIENT FLUSH WAS MAINTAINED. ACCORDING TO THE EVENT DESCRIPTION, FLUSH WAS INCREASED AFTER THE FIRST ATTEMPT TO ADVANCE THE EMBOLIC COIL THROUGH THE MICROCATHETER. THE IFU STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. THE COMPLAINT DESCRIPTION DOES NOT REFERENCE THE SEVERING OF THE DPU CORE WIRE. THIS MAY HAVE BEEN DONE AFTER THE EVENT TO SEPARATE THE DEVICES FOR RETURN. BASED ON THE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE IT APPEARS THAT CIRCUMSTANCES OF THE PROCEDURE POSSIBLY CONTRIBUTED TO THE REPORTED FAILURE WITH NO INDICATION OF A RELATIONSHIP TO THE DEVICE MANUFACTURING PROCESS; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE REPORTED COMPLAINT THAT THE PROWLER SEL PLUS 150/5CM 45TIP/LOT # 17665864 MICROCATHETER WAS OBSTRUCTED WAS CONFIRMED DURING FUNCTIONAL TESTING. IT APPEARS THAT THE FAILURE MAY HAVE OCCURRED DUE TO THE KINKED CONDITION OF THE MICROCATHETER. THE KINKED CONDITION MAY HAVE BEEN CAUSED BY THE APPLICATION OF EXCESSIVE FORCE. BASED ON THE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE IT APPEARS THAT CIRCUMSTANCES OF THE PROCEDURE POSSIBLY CONTRIBUTED TO THE REPORTED FAILURE WITH NO INDICATION OF A RELATIONSHIP TO THE DEVICE MANUFACTURING PROCESS; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE COMPLAINT THAT THE MICRUSFRAME18 20MM X 50CM/LOT # S14024 INTRODUCER EXPERIENCED PREMATURE PEELING WAS CONFIRMED. THE EMBOLIC COIL PROTRUDED FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH DISTAL TO THE RESHEATHING TOOL. THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE REPORTED EVENT. ACCORDING TO THE COMPLAINT DESCRIPTION, AN ANGIO CATHETER WAS INSERTED THROUGH THE GUIDING SHEATHE, AND AN EXCELSIOR 1018 MICROCATHETER WAS INSERTED THROUGH THE ANGIO CATHETER. THE MICRUSFRAME18 DEVICE WAS REPORTEDLY INSERTED THROUGH THE EXCELSIOR MICROCATHETER. HOWEVER, NO EXCELSIOR MICROCATHETER OR ANGIO CATHETER WAS RETURNED, AND THE MICRUSFRAME18 APPEARED TO BE ANCHORED IN THE GUIDING SHEATH. THE PROTRUSION OF THE EMBOLIC COIL THROUGH THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH WAS MOST LIKELY A RESULT OF ADVANCING THE RESHEATHING TOOL OVER THE EMBOLIC COIL WHILE UNSHEATHING THE DEVICE. THE IFU INSTRUCTS THE USER TO UNSHEATHE A SMALL LENGTH OF THE DPU TO UNLOCK THE DEVICE, THEN TO ADVANCE THE EMBOLIC COIL INTO THE MICROCATHETER UNTIL THE HUB CONNECTOR OF THE DPU REACHES THE PROXIMAL END OF THE RESHEATHING TOOL. THIS RESULTS IN THE PLACEMENT OF THE EMBOLIC COIL INSIDE THE MICROCATHETER BEFORE CONTINUING TO UNSHEATHE THE DEVICE. IF THE DEVICE IS UNSHEATHED BEFORE ADVANCING THE EMBOLIC COIL INTO THE MICROCATHETER, THERE IS A RISK THAT THE EMBOLIC COIL WILL BE UNSHEATHED AND PASS THROUGH THE RESHEATHING TOOL. THIS CAN CAUSE DAMAGE TO THE EMBOLIC COIL AND CAN ALSO CAUSE IT TO PROTRUDE FROM THE INTRODUCER. IN THIS INSTANCE, IT ALSO APPEARED AS THOUGH THE EMBOLIC COIL BECAME ANCHORED IN THE GUIDING SHEATH, WHICH WOULD INDICATE THAT THE EMBOLIC COIL WAS NOT BEING INTRODUCED THROUGH A MICROCATHETER, BUT DIRECTLY THROUGH THE GUIDING SHEATH. THE EMBOLIC COIL BECAME STRETCHED DURING THIS EVENT. THE BROKEN RESHEATHING TOOL AND BENDS IN THE DPU CORE WIRE INDICATE THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE PRESENCE OF THE FOLDED SECTIONS OF EXTENDED COIL, MARKER BAND, AND TIP COIL INDICATES THAT EXCESSIVE FORCE WAS APPLIED AFTER THE EMBOLIC COIL BECAME ANCHORED IN THE GUIDING SHEATH. THESE SECTIONS OF THE DPU ARE PROXIMAL TO THE EMBOLIC COIL, AND WERE APPARENTLY FORCED PAST THE EMBOLIC COIL. IT IS NOT CLEAR HOW THE RESHEATHING TOOL BECAME EMBEDDED IN THE PROXIMAL END OF THE GUIDING SHEATH. THE PRESENCE OF BLOOD THROUGHOUT THE TRANSLUCENT INTRODUCER SHEATH AND ON THE EMBOLIC COIL SUGGESTS THAT AN INSUFFICIENT FLUSH WAS MAINTAINED. THE IFU STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. BASED ON THE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE IT APPEARS THAT DEVICE MANIPULATION AND/OR PROCEDURAL/HANDLING FACTORS CONTRIBUTED TO THE REPORTED FAILURE WITH NO INDICATION OF A RELATIONSHIP TO THE DEVICE MANUFACTURING PROCESS; HOWEVER, DUE TO THE LACK OF PROCEDURAL INFORMATION AND BASED ON THE ANALYSIS, A DEFINITIVE ROOT CAUSE CONCLUSION REGARDING THE REPORTED EVENT CANNOT BE DETERMINED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF THREE PRODUCTS ASSOCIATED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1226348-2018-00504, 1226348-2018-005043008114965-2018-00506.
PRODUCT COMPLAINT # (B)(4). BASED ON THE PRODUCT ANALYSIS FINDINGS MADE AVAILABLE ON 1/12/2018, THIS PRODUCT COMPLAINT HAS BEEN DEEMED FDA MDR REPORTABLE. THE MICRUSFRAME COIL WAS FOUND TO BE STRETCHED. INFORMATION REGARDING PATIENT WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) CONCOMITANT MED PRODUCTS: DELTAFILL18 (DLF182460/S13373), PROWLER SELECT PLUS (606-S255FX/ 17665864) MC, DCB02 CONTROL BOX, EXCELSIOR 1018 (STRYKER) MC, 4F SHEATHLESS PV (ASAHI INTECC) GC, Y-CONNECTOR (TERUMO), ENPOWER CONTROL CABLE INITIAL REPORTER - THE CUSTOMER CONTACT INFORMATION WAS NOT PROVIDED. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RENAL ARTERY ANEURYSM, A 24 MM X 60 CM DELTAFILL 18 THERMO-MECHANICAL COIL (DLF182460/S13373) WAS FLUSHED AND INSERTED INTO THE 150/5 CM 45TIP PROWLER SELECT PLUS MICROCATHETER (606-S255FX/17665864); HOWEVER, RESISTANCE WAS FELT AT THE MID-PORTION OF THE MICROCATHETER. THE COIL DELIVERY SYSTEM WAS REMOVED AND FLUSHING LEVEL WAS INCREASED. AFTER THE MICROCATHETER WAS FLUSHED, THE COIL DELIVERY SYSTEM WAS RE-INSERTED BUT STRONG RESISTANCE WAS STILL FELT AT THE MID-PORTION OF THE MICROCATHETER. THE COIL COULD NOT BE RETRACTED; THEREFORE, THE COIL AND THE MICROCATHETER WERE REMOVED AS A UNIT. THE PROWLER SELECT PLUS MICROCATHETER WAS REPLACED WITH A COMPETITOR PRODUCT AND THE COIL WAS REPLACED WITH A 20 MM X 50 CM MICRUSFRAME18 (MFR182050/S14024) THERMO-MECHANICAL COIL. THE PHYSICIAN ATTEMPTED TO INSERT THE MICRUSFRAME18 COIL DELIVERY SYSTEM, BUT THE SHEATH SLIT AND THE PRODUCT COULD NOT BE USED. THE COIL WAS SUBSEQUENTLY REPLACED. IN TOTAL, 20 DELTAFILL COILS WERE IMPLANTED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S VESSEL WAS MILDLY TORTUOUS AND NOT CALCIFIED. A DCB02 CONTROL BOX, AN EXCELSIOR 1018 (STRYKER), A 4F SHEATHLESSPV (ASAHI INTECC) GUIDING CATHETER, A Y-CONNECTOR (TERUMO), AND AN ENPOWER CONTROL CABLE WERE ALSO USED FOR THE CASE. AN ANGIOCATHETER WAS INSERTED INTO THE GUIDING SHEATH. THE PROWLER SELECT PLUS MICROCATHETER WAS THEN INSERTED TO INITIATE COILING. THE MICROCATHETER WAS PLACED IN THE ANEURYSM AND A MICRUSFRAME 20 MM COIL WAS INSERTED. HOWEVER, IT WAS UNDERSIZED AND REMOVED FROM THE PATIENT. THE DELTAFILL18 COIL WAS THEN DELTAFILL18 PREPARED FOR USE. THE PRODUCTS WERE STERILE AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND FOLLOWING THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCTS WERE RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED INSERTED THROUGH A CONCOMITANT DEVICE, MOST LIKELY THE GUIDING SHEATH REFERENCED IN THE COMPLAINT. THE CONCOMITANT DEVICE WAS BLUE AND SLIT LENGTHWISE. THE EMBOLIC COIL PROTRUDED THROUGH THE SLIT IN THE CONCOMITANT DEVICE. PART OF THE DISTAL END OF THE DEVICE POSITIONING UNIT (DPU) EXITED THE CONCOMITANT DEVICE, FOLDED OVER, AND RE-ENTERED IT. THE RESHEATHING TOOL WAS BROKEN. THE DISTAL END OF THE RESHEATHING TOOL WAS EMBEDDED IN THE PROXIMAL END OF THE CONCOMITANT DEVICE. THERE WAS BLOOD THROUGHOUT THE TRANSLUCENT INTRODUCER SHEATH. THERE WERE BENDS IN THE DPU CORE WIRE APPROXIMATELY 7 CM AND 157 CM FROM THE PROXIMAL END. THE BALL TIP WAS INTACT. THERE WAS BLOOD ON THE EMBOLIC COIL. THE EMBOLIC COIL PROTRUDED FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. THE EMBOLIC COIL PASSED INTO THE CONCOMITANT DEVICE, THE EXTENDED COIL EXITED, THEN BENDED OVER, AND THE DPU CORE WIRE RE-ENTERED THE DEVICE. THE MARKER BAND WAS KINKED. THE EMBOLIC COIL THAT PROTRUDED FROM THE SLIT IN THE CONCOMITANT DEVICE WAS STRETCHED. THE ARTICULATING JOINT WAS INTACT. THE RESISTANCE HEATING (RH) COIL WAS INSIDE THE CONCOMITANT DEVICE AND COULD NOT BE OBSERVED. WHILE THE RESHEATHING TOOL WAS BROKEN, THE V-NOTCH WAS UNDAMAGED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COMPLAINT THAT THE INTRODUCER EXPERIENCED PREMATURE PEELING WAS CONFIRMED. THE EMBOLIC COIL PROTRUDED FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH DISTAL TO THE RESHEATHING TOOL. THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE REPORTED EVENT. ACCORDING TO THE COMPLAINT DESCRIPTION, AN ANGIO CATHETER WAS INSERTED THROUGH THE GUIDING SHEATHE, AND AN EXCELSIOR 1018 MICROCATHETER WAS INSERTED THROUGH THE ANGIO CATHETER. THE MICRUSFRAME18 DEVICE WAS REPORTEDLY INSERTED THROUGH THE EXCELSIOR MICROCATHETER. HOWEVER, NO EXCELSIOR MICROCATHETER OR ANGIO CATHETER WAS RETURNED, AND THE MICRUSFRAME18 APPEARED TO BE ANCHORED IN THE GUIDING SHEATH. THE PROTRUSION OF THE EMBOLIC COIL THROUGH THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH WAS MOST LIKELY A RESULT OF ADVANCING THE RESHEATHING TOOL OVER THE EMBOLIC COIL WHILE UNSHEATHING THE DEVICE. THE IFU INSTRUCTS THE USER TO UNSHEATHE A SMALL LENGTH OF THE DPU TO UNLOCK THE DEVICE, THEN TO ADVANCE THE EMBOLIC COIL INTO THE MICROCATHETER UNTIL THE HUB CONNECTOR OF THE DPU REACHES THE PROXIMAL END OF THE RESHEATHING TOOL. THIS RESULTS IN THE PLACEMENT OF THE EMBOLIC COIL INSIDE THE MICROCATHETER BEFORE CONTINUING TO UNSHEATHE THE DEVICE. IF THE DEVICE IS UNSHEATHED BEFORE ADVANCING THE EMBOLIC COIL INTO THE MICROCATHETER, THERE IS A RISK THAT THE EMBOLIC COIL WILL BE UNSHEATHED AND PASS THROUGH THE RESHEATHING TOOL. THIS CAN CAUSE DAMAGE TO THE EMBOLIC COIL AND CAN ALSO CAUSE IT TO PROTRUDE FROM THE INTRODUCER. IN THIS INSTANCE, IT ALSO APPEARED AS THOUGH THE EMBOLIC COIL BECAME ANCHORED IN THE GUIDING SHEATH, WHICH WOULD INDICATE THAT THE EMBOLIC COIL WAS NOT BEING INTRODUCED THROUGH A MICROCATHETER, BUT DIRECTLY THROUGH THE GUIDING SHEATH. THE EMBOLIC COIL BECAME STRETCHED DURING THIS EVENT. THE BROKEN RESHEATHING TOOL AND BENDS IN THE DPU CORE WIRE INDICATE THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE PRESENCE OF THE FOLDED SECTIONS OF EXTENDED COIL, MARKER BAND, AND TIP COIL INDICATES THAT EXCESSIVE FORCE WAS APPLIED AFTER THE EMBOLIC COIL BECAME ANCHORED IN THE GUIDING SHEATH. THESE SECTIONS OF THE DPU ARE PROXIMAL TO THE EMBOLIC COIL, AND WERE APPARENTLY FORCED PAST THE EMBOLIC COIL. IT IS NOT CLEAR HOW THE RESHEATHING TOOL BECAME EMBEDDED IN THE PROXIMAL END OF THE GUIDING SHEATH. THE PRESENCE OF BLOOD THROUGHOUT THE TRANSLUCENT INTRODUCER SHEATH AND ON THE EMBOLIC COIL SUGGESTS THAT AN INSUFFICIENT FLUSH WAS MAINTAINED. THE IFU STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. BASED ON THE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE IT APPEARS THAT DEVICE MANIPULATION AND/OR PROCEDURAL/HANDLING FACTORS CONTRIBUTED TO THE REPORTED FAILURE WITH NO INDICATION OF A RELATIONSHIP TO THE DEVICE MANUFACTURING PROCESS; HOWEVER, DUE TO THE LACK OF PROCEDURAL INFORMATION AND BASED ON THE ANALYSIS, A DEFINITIVE ROOT CAUSE CONCLUSION REGARDING THE REPORTED EVENT CANNOT BE DETERMINED. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF THREE PRODUCTS ASSOCIATED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1226348-2018-00504, 1226348-2018-005043008114965-2018-00506, & 3008114965-2018-00510.
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RENAL ARTERY ANEURYSM, A 24 MM X 60 CM DELTAFILL18 THERMO-MECHANICAL COIL (DLF182460/S13373) WAS FLUSHED AND INSERTED INTO THE 150/5 CM 45TIP PROWLER SELECT PLUS MICROCATHETER (606-S255FX/17665864); HOWEVER, RESISTANCE WAS FELT AT THE MID-PORTION OF THE MICROCATHETER. THE COIL DELIVERY SYSTEM WAS REMOVED AND FLUSHING LEVEL WAS INCREASED. AFTER THE MICROCATHETER WAS FLUSHED, THE COIL DELIVERY SYSTEM WAS RE-INSERTED BUT STRONG RESISTANCE WAS STILL FELT AT THE MID-PORTION OF THE MICROCATHETER. THE COIL COULD NOT BE RETRACTED; THEREFORE, THE COIL AND THE MICROCATHETER WERE REMOVED AS A UNIT. THE PROWLER SELECT PLUS MICROCATHETER WAS REPLACED WITH A COMPETITOR PRODUCT AND THE COIL WAS REPLACED WITH A 20 MM X 50 CM MICRUSFRAME18 (MFR182050/S14024) THERMO-MECHANICAL COIL. THE PHYSICIAN ATTEMPTED TO INSERT THE MICRUSFRAME18 COIL DELIVERY SYSTEM, BUT THE SHEATH SLIT AND THE PRODUCT COULD NOT BE USED. THE COIL WAS SUBSEQUENTLY REPLACED. IN TOTAL, 20 DELTAFILL COILS WERE IMPLANTED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S VESSEL WAS MILDLY TORTUOUS AND NOT CALCIFIED. A DCB02 CONTROL BOX, AN EXCELSIOR 1018 (STRYKER), A 4F SHEATHLESSPV (ASAHI INTECC) GUIDING CATHETER, A Y-CONNECTOR (TERUMO), AND AN ENPOWER CONTROL CABLE WERE ALSO USED FOR THE CASE. AN ANGIOCATHETER WAS INSERTED INTO THE GUIDING SHEATH. THE PROWLER SELECT PLUS MICROCATHETER WAS THEN INSERTED TO INITIATE COILING. THE MICROCATHETER WAS PLACED IN THE ANEURYSM AND A MICRUS FRAMING 20 MM COIL WAS INSERTED. HOWEVER, IT WAS UNDERSIZED AND REMOVED FROM THE PATIENT. THE DELTAFILL18 COIL WAS THEN DELTAFILL18 PREPARED FOR USE. THE PRODUCTS WERE STERILE AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND FOLLOWING THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCTS WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61525 | MICRUSFRAME18 20MM X 50CM | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | REFER TO SECTION H10 | S14024 | 10886704078173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |