GALAXY G3 XSFT HEL 2MM X 8CM
Report
- Report Number
- 3008114965-2021-00066
- Event Type
- Injury
- Date Received
- February 16, 2021
- Date of Event
- January 26, 2021
- Report Date
- January 26, 2021
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- KRD
- UDI-DI
- 10886704077763
- PMA / PMN Number
- K150319
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE RETURNED COMPLAINT DEVICE ON (B)(6) 2021. THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED, AFTER THE PERIPHERAL VESSELS WERE EMBOLIZED WITH SEVERAL COILS, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / K10419) WAS USED AS THE FIRST COIL. IT WAS INSERTED INTO THE CONCOMITANT PROGREAT ALPHA¿ 19 MICROCATHETER (TERUMO), BUT THERE WAS INTENSE RESISTANCE FELT BEFORE THE COIL EXITED THE MICROCATHETER INTO THE BLOOD VESSEL. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME DETACHED IN THE BLOOD VESSEL. THE PREMATURELY DETACHED COIL WAS REMOVED USING A MICRO SNARE AND WAS REPLACED WITH A COMPETITOR COIL WHICH WAS USED AND PLACED WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DEVICE POSITIONING UNIT IS OBSERVED KINKED AND STUCK IN THE INTRODUCER WITH DRIED BLOOD RESIDUES. THE CORE WIRE WAS ALSO OBSERVED WITH SEVERAL KINKED AREAS AND HAS RESIDUES OF DRIED BLOOD ON IT. NO OTHER DAMAGE NOR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. THE MARKER BAND WAS FOUND AT 43CM FROM THE HUB; THIS IS WITHIN SPECIFICATION. MICROSCOPIC INSPECTION WAS PERFORMED. THE EMBOLIC COIL WAS OBSERVED IN GOOD NORMAL CONDITION INSIDE THE INTRODUCER. THE EMBOLIC COIL WAS NOT IN A DETACHED STATE. FUNCTIONAL TESTING COULD NOT BE PERFORMED. ALTHOUGH THE DEVICE WAS FLUSHED, THE DRIED BLOOD RESIDUES COULD NOT BE REMOVED FROM THE DPU, THIS PRECLUDES THE DEVICE FROM UNDERGOING FUNCTIONAL EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10419) 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 REPORTED THAT AFTER THE PERIPHERAL VESSELS WERE EMBOLIZED, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL WAS USED AND WAS INSERTED INTO THE CONCOMITANT PROGREAT ALPHA¿ 19 MICROCATHETER (TERUMO), BUT THERE WAS INTENSE RESISTANCE FELT BEFORE THE COIL EXITED THE MICROCATHETER INTO THE BLOOD VESSEL. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME DETACHED IN THE BLOOD VESSEL. THE PREMATURELY DETACHED COIL WAS REMOVED USING A MICRO SNARE AND WAS REPLACED WITH A COMPETITOR COIL WHICH WAS USED AND PLACED WITHOUT ANY ISSUE. THE REPORTED ISSUE RELATED TO THE RESISTANCE WAS CONFIRMED. DURING THE ANALYSIS, IT WAS OBSERVED THAT THE DPU IS STUCK INSIDE THE INTRODUCER WITH RESIDUES OF DRIED BLOOD. THE PRESENCE OF THE DRIED BLOOD RESIDUES INDICATES THAT CONTINUOUS AND ADEQUATE FLUSH WAS NOT MAINTAINED DURING THE PROCEDURE. THE KINKED CONDITION OBSERVED ON THE DPU IS LIKELY DUE TO FORCE APPLIED ON THE DEVICE, THOUGH THIS CANNOT BE CONCLUSIVELY DETERMINED. THE REPORTED PREMATURE DETACHMENT OF THE COIL WAS NOT CONFIRMED. THE EMBOLIC COIL IS STILL INSIDE THE INTRODUCER ATTACHED TO THE REST OF THE DEVICE COMPONENT AND IN GOOD, NORMAL CONDITION. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. UNUSUAL RESISTANCE AND FRICTION DURING ADVANCEMENT AND PREMATURE DETACHMENT NECESSITATING ADDITIONAL INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF EMBOLIC COILS IN ENDOVASCULAR EMBOLIZATION. THE GALAXY G3 INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM, EXAMINE FOR DAMAGE, AND REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW, AND EXAMINE THE DELIVERY CATHETER SYSTEM. IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES. EXCESSIVE FORCE APPLIED TO A COIL THROUGH REPEATED COIL DEPLOYMENTS OR MANIPULATION CAN INCREASE THE POSSIBILITY OF PREMATURE DETACHMENT. WITH THE AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENTS. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE SELECTION, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. SINCE THE ALLEGED PRODUCT FAILURES NECESSITATED ADDITIONAL INTERVENTION (I.E. USE OF SNARE) TO PRECLUDE PATIENT COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY.¿ 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. H6: INVESTIGATION FINDINGS/INVESTIGATION CONCLUSIONS: THE ¿NO DEVICE PROBLEM FOUND¿ CODE WAS USED IN THE INVESTIGATION FINDINGS BECAUSE THE REPORTED ISSUE OF PREMATURE DETACHMENT WAS NOT CONFIRMED DURING THE FUNCTIONAL EVALUATION OF THE RETURNED DEVICE. THIS CODE CORRESPONDS TO THE CODE ¿NO PROBLEM DETECTED¿ CODE IN THE INVESTIGATION CONCLUSIONS. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE ADDITIONAL EVENT INFORMATION RECEIVED ON 06 APRIL 2021. THE DEVICE WAS RETURNED WITH THE EMBOLIC COIL IN GOOD CONDITION (NOT DETACHED). FOLLOW-UP INVESTIGATION WAS PERFORMED TO CONFIRM IF THE CORRECT COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 24 MAR 2021 INDICATED THAT ¿THE DELIVERY WIRE WAS SO HARD DURING DELIVERING TO THE LESION¿ THAT IT BECAME STUCK. THE DEVICE WAS NOT RETRIEVED BY A SNARE. FURTHER INFORMATION WAS RECEIVED ON 06 APR 2021 INDICATED THAT THE ORIGINALLY REPORTED ISSUE THAT THE COIL BECAME PREMATURELY DETACHED AND SEPARATED IN THE MICROCATHETER IS NOT CORRECT. THE REPORTING PHYSICIAN CONFIRMED THAT THE COIL WAS NOT DETACHED AND THERE WAS NO MEDICAL INTERVENTION VIA THE USE OF A SNARE. THE ACTUAL COMPLAINT IS RELATED TO THE FAILURE OF THE DELIVERY WIRE TO DELIVER THE COIL TO THE TARGET LESION. DEVICE IMPEDED IS A KNOWN EVENT. REMOVAL AND EXCHANGE OF DEVICES IS COMMON ROUTINE PRACTICE IN ENDOVASCULAR PROCEDURES. IN THIS CASE, THE EXCHANGE OF THE DEVICE WAS DONE WITHOUT LOSS OF INTRACRANIAL TARGET POSITION. THIS IS A COMMON PRACTICE DURING PROCEDURES AND IS RECOMMENDED IN PRODUCT IFU¿S. SINCE THE VAST MAJORITY OF DIAGNOSTIC AND INTERVENTIONAL ANGIOGRAPHIC PROCEDURES UTILIZE MULTIPLE DEVICE EXCHANGES, AN INCREASED POTENTIAL FOR PATIENT INJURY IS REMOTE. FURTHERMORE, THE PHYSICIAN CONFIRMED THAT THE COMPLAINT COIL DID NOT DETACH FROM THE DELIVERY SYSTEM, AND THERE WAS NO MEDICAL INTERVENTION VIA THE USE OF A SNARE. UPON FURTHER REVIEW, THIS COMPLAINT DOES NOT MEET THE CRITERIA FOR MEDICAL DEVICE REPORTING SINCE THERE WAS NO ADVERSE EVENT; THERE WAS NO MEDICAL INTERVENTION VIA THE USE OF A SNARE. THEREFORE, IT HAS BEEN DEEMED NOT REPORTABLE. NO FURTHER REPORTS WILL BE FORTHCOMING. UPDATED SECTIONS: G.3, G.6, H.2, H.6, AND H.10.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO MAKE A CORRECTION TO THE EVENT CODING. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED, AFTER THE PERIPHERAL VESSELS WERE EMBOLIZED WITH SEVERAL COILS, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / K10419) WAS USED AS THE FIRST COIL. IT WAS INSERTED INTO THE CONCOMITANT PROGREAT ALPHA¿ 19 MICROCATHETER (TERUMO), BUT THERE WAS INTENSE RESISTANCE FELT BEFORE THE COIL EXITED THE MICROCATHETER INTO THE BLOOD VESSEL. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME DETACHED IN THE BLOOD VESSEL. THE PREMATURELY DETACHED COIL WAS REMOVED USING A MICRO SNARE AND WAS REPLACED WITH A COMPETITOR COIL WHICH WAS USED AND PLACED WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DEVICE POSITIONING UNIT IS OBSERVED KINKED AND STUCK IN THE INTRODUCER WITH DRIED BLOOD RESIDUES. THE CORE WIRE WAS ALSO OBSERVED WITH SEVERAL KINKED AREAS AND HAS RESIDUES OF DRIED BLOOD ON IT. NO OTHER DAMAGE NOR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. THE MARKER BAND WAS FOUND AT 43CM FROM THE HUB; THIS IS WITHIN SPECIFICATION. MICROSCOPIC INSPECTION WAS PERFORMED. THE EMBOLIC COIL WAS OBSERVED IN GOOD NORMAL CONDITION INSIDE THE INTRODUCER. THE EMBOLIC COIL WAS NOT IN A DETACHED STATE. FUNCTIONAL TESTING COULD NOT BE PERFORMED. ALTHOUGH THE DEVICE WAS FLUSHED, THE DRIED BLOOD RESIDUES COULD NOT BE REMOVED FROM THE DPU, THIS PRECLUDES THE DEVICE FROM UNDERGOING FUNCTIONAL EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10419) 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 REPORTED THAT AFTER THE PERIPHERAL VESSELS WERE EMBOLIZED, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL WAS USED AND WAS INSERTED INTO THE CONCOMITANT PROGREAT ALPHA¿ 19 MICROCATHETER (TERUMO), BUT THERE WAS INTENSE RESISTANCE FELT BEFORE THE COIL EXITED THE MICROCATHETER INTO THE BLOOD VESSEL. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME DETACHED IN THE BLOOD VESSEL. THE PREMATURELY DETACHED COIL WAS REMOVED USING A MICRO SNARE AND WAS REPLACED WITH A COMPETITOR COIL WHICH WAS USED AND PLACED WITHOUT ANY ISSUE. THE REPORTED ISSUE RELATED TO THE RESISTANCE WAS CONFIRMED. DURING THE ANALYSIS, IT WAS OBSERVED THAT THE DPU IS STUCK INSIDE THE INTRODUCER WITH RESIDUES OF DRIED BLOOD. THE PRESENCE OF THE DRIED BLOOD RESIDUES INDICATES THAT CONTINUOUS AND ADEQUATE FLUSH WAS NOT MAINTAINED DURING THE PROCEDURE. INSUFFICIENT FLUSH CAN LEAD TO ISSUE SUCH AS RESISTANCE FRICTION AS REPORTED IN THE COMPLAINT. THE KINKED CONDITION OBSERVED ON THE DPU IS LIKELY DUE TO FORCE APPLIED ON THE DEVICE, THOUGH THIS CANNOT BE CONCLUSIVELY DETERMINED. THE REPORTED PREMATURE DETACHMENT OF THE COIL WAS NOT CONFIRMED. THE EMBOLIC COIL IS STILL INSIDE THE INTRODUCER ATTACHED TO THE REST OF THE DEVICE COMPONENT AND IN GOOD, NORMAL CONDITION. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. UNUSUAL RESISTANCE AND FRICTION DURING ADVANCEMENT AND PREMATURE DETACHMENT NECESSITATING ADDITIONAL INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF EMBOLIC COILS IN ENDOVASCULAR EMBOLIZATION. THE GALAXY G3 INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM, EXAMINE FOR DAMAGE, AND REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW AND EXAMINE THE DELIVERY CATHETER SYSTEM. IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES. WITH THE AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE SELECTION, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. EXCESSIVE FORCE APPLIED TO A COIL THROUGH REPEATED COIL DEPLOYMENTS OR MANIPULATION CAN INCREASE THE POSSIBILITY OF PREMATURE DETACHMENT. SINCE THE ALLEGED PRODUCT FAILURES NECESSITATED ADDITIONAL INTERVENTION (I.E. USE OF SNARE) TO PRECLUDE PATIENT COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY.¿ 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. H.6: THE ORIGINALLY REPORTED DIFFICULT TO ADVANCE CODE WAS RELATED TO THE COIL RESISTANCE/FRICTION; IT HAS BEEN CORRECTED TO DIFFICULT TO ADVANCE AS RELATED TO THE DETACHABLE COIL DELIVERY SYSTEM (DCS) RESISTANCE/FRICTION. H.6: THE ORIGINALLY REPORTED PREMATURE SEPARATION WAS RELATED TO THE PREMATURE DETACHMENT DURING COIL PLACEMENT; IT HAS BEEN CORRECTED TO PREMATURE SEPARATION AS RELATED TO PREMATURE DETACHMENT IN THE MICROCATHETER DURING REMOVAL.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 10 MARCH 2021. E.1: INITIAL REPORTER PHONE: (B)(6). [ADDITIONAL INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED, AFTER THE PERIPHERAL VESSELS WERE EMBOLIZED WITH SEVERAL COILS, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / K10419) WAS USED AS THE FIRST COIL. IT WAS INSERTED INTO THE CONCOMITANT PROGREAT ALPHA¿ 19 MICROCATHETER (TERUMO), BUT THERE WAS INTENSE RESISTANCE FELT BEFORE THE COIL EXITED THE MICROCATHETER INTO THE BLOOD VESSEL. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME DETACHED IN THE BLOOD VESSEL. THE PREMATURELY DETACHED COIL WAS REMOVED USING A MICRO SNARE AND WAS REPLACED WITH A COMPETITOR COIL WHICH WAS USED AND PLACED WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 10 MARCH 2021, ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT A CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGH THE CONCOMITANT MICROCATHETER. THE EMBOLIC COIL BECAME SEPARATED AND WAS RELEASED INTO THE BLOOD VESSEL. THERE WAS NO EVIDENCE OF BLOOD FLOW REDUCTION / RESTRICTION AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY CLINICALLY SIGNIFICANT PROCEDURE DELAY. UNUSUAL RESISTANCE AND FRICTION DURING ADVANCEMENT AND DEVICE SEPARATION NECESSITATING ADDITIONAL INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF EMBOLIC COILS IN ENDOVASCULAR EMBOLIZATION. THE GALAXY G3 INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM, EXAMINE FOR DAMAGE, AND REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW, AND EXAMINE THE DELIVERY CATHETER SYSTEM. IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES. WITH THE AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE SELECTION, DEVICE INTERACTION, INADEQUATE FLUSH, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. EXCESSIVE FORCE APPLIED TO A COIL THROUGH REPEATED COIL DEPLOYMENTS OR MANIPULATION CAN INCREASE THE POSSIBILITY OF PREMATURE DETACHMENT. SINCE THE ALLEGED PRODUCT FAILURES NECESSITATED ADDITIONAL INTERVENTION (I.E. USE OF SNARE) TO PRECLUDE PATIENT COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY.¿ THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. (B)(4). THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10419) 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. UNUSUAL RESISTANCE AND FRICTION DURING ADVANCEMENT AND PREMATURE DETACHMENT NECESSITATING ADDITIONAL INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF EMBOLIC COILS IN ENDOVASCULAR EMBOLIZATION. THE GALAXY G3 INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM, EXAMINE FOR DAMAGE, AND REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW AND EXAMINE THE DELIVERY CATHETER SYSTEM. IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES. EXCESSIVE FORCE APPLIED TO A COIL THROUGH REPEATED COIL DEPLOYMENTS OR MANIPULATION CAN INCREASE THE POSSIBILITY OF PREMATURE DETACHMENT. WITH THE AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENTS. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE SELECTION, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. SINCE THE ALLEGED PRODUCT FAILURES NECESSITATED ADDITIONAL INTERVENTION (I.E. USE OF SNARE) TO PRECLUDE PATIENT COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY.¿ 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 MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED, AFTER THE PERIPHERAL VESSELS WERE EMBOLIZED WITH SEVERAL COILS, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / K10419) WAS USED AS THE FIRST COIL. IT WAS INSERTED INTO THE CONCOMITANT PROGREAT ALPHA¿ 19 MICROCATHETER (TERUMO), BUT THERE WAS INTENSE RESISTANCE FELT BEFORE THE COIL EXITED THE MICROCATHETER INTO THE BLOOD VESSEL. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME DETACHED IN THE BLOOD VESSEL. THE PREMATURELY DETACHED COIL WAS REMOVED USING A MICRO SNARE AND WAS REPLACED WITH A COMPETITOR COIL WHICH WAS USED AND PLACED WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231590 | GALAXY G3 XSFT HEL 2MM X 8CM | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | MEDOS INTERNATIONAL SARL | GLX120208 | K10419 | 10886704077763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MICRO SNARE (UNSPECIFIED BRAND)| PROGREAT ALPHA¿ 19 MICROCATHETER (TERUMO) |