EMBOTRAP II 5X33 REVASC. DEV.
Report
- Report Number
- 3011370111-2018-00107
- Event Type
- Malfunction
- Date Received
- November 15, 2018
- Report Date
- November 14, 2018
- Manufacturer
- NEURAVI LIMITED
- Product Code
- NRY
- UDI-DI
- 10886704081326
- PMA / PMN Number
- K173452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # ==> (B)(4). [COMPLAINT CONCLUSION] AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY, THE USER ENCOUNTERED HIGH RETRIEVAL FORCE WHILE WITHDRAWING THE 5X33 EMBOTRAP II (ET007533/17E080AV) REVASCULARIZATION DEVICE THROUGH THE 6F SOFIA (MICROVENTION) INTERMEDIATE CATHETER. THE USER STOPPED AND REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. POSTOPERATIVELY, THE USER ATTEMPTED TO REMOVE THE EMBOTRAP II PROXIMALLY THROUGH THE SOFIA CATHETER WITH GREAT EFFORT, AND A WIRE MESH BELONGING TO THE SOFIA CATHETER WAS RETRIEVED. THE EMBOTRAP II, ON THE OTHER HAND, WAS UNAFFECTED BY THE MECHANICAL TREATMENT. REPORTEDLY, THE USER WAS ABLE TO REMOVE THE EMBOTRAP II FROM THE SOFIA OUTSIDE OF THE PATIENT. THE THROMBUS WAS TRAPPED INSIDE OF THE EMBOTRAP II AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 (COMPLETE PERFUSION) WAS ABLE TO BE ACHIEVED ON FIRST PASS. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURAL DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT, AS THE ISSUE OCCURRED FOLLOWING THE PROCEDURE. THERE WAS NO EVIDENCE OF THROMBOEMBOLISM DUE TO THE REPORTED WITHDRAWAL DIFFICULTY. THE LAST REPORT RECEIVED INDICATED THAT THE PATIENT IS DOING FINE. AN UNSPECIFIED 0.021¿ MICROCATHETER WAS USED IN THE CASE. IT IS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED WITHIN THE CATHETER. THE USER APPLIED UNDUE FORCE WHEN THE EMBOTRAP II BECAME STUCK INSIDE OF THE SOFIA CATHETER. AT THIS TIME, THE ENTIRE CATHETER SYSTEM HAD ALREADY BEEN REMOVED FROM THE PATIENT. UPON REMOVAL, THE USER NOTICED THAT PIECES OF THE SOFIA¿S INNER MESH/BRAIDING HAD SEPARATED AND EXITED THE CATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED TO THE EMBOTRAP II DEVICE. DETAILS REGARDING THE INTENDED TARGET VESSEL, CLOT CHARACTERISTICS, AND PRE-PROCEDURE TICI SCORE WERE NOT REPORTED. NO FURTHER INFORMATION COULD BE OBTAINED. THE 5X33 EMBOTRAP II DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED INSIDE OF THE ORIGINAL PACKAGING CARTON. INSIDE THE ORIGINAL PACKAGING CARTON, THE EMBOTRAP HAD BEEN PLACED IN AN UNSEALED POUCH. THE DEVICE HAD BEEN RESHEATHED INTO THE INSERTION TOOL. A SECOND UNSEALED POUCH IN THE UNIT CARTON CONTAINED THE PROXIMAL SECTION OF THE SOFIA PLUS INTERMEDIATE CATHETER WHICH HAD BEEN CUT FROM THE REMAINDER OF THE CATHETER. A WIRE 'MESH' WAS ALSO FOUND LOOSE INSIDE THE UNIT CARTON. VISUAL INSPECTION CONDUCTED PRIOR TO DISINFECTION REVEALED NO DAMAGE ON THE SHAFT OR INSERTION TOOL OF THE EMBOTRAP. AFTER THE DEVICE WAS DISINFECTED, THE EMBOTRAP WAS DEPLOYED FROM THE INSERTION TOOL AS NORMAL, WITHOUT RESISTANCE. THE EMBOTRAP EXPANDED AS EXPECTED WITH NO DAMAGE OR DEFORMITIES NOTED. THE INNER CHANNEL AND OUTER CAGE COMPONENTS WERE INSPECTED UNDER HIGH MAGNIFICATION. NO EVIDENCE OF DAMAGE WAS OBSERVED ON EITHER COMPONENT. THERE WAS NO EVIDENCE OF STRUT FRACTURE OR KINKING ON THE DEVICE COMPONENTS. NO DAMAGE WAS OBSERVED ON THE DISTAL CONE OR EXPANDED STRUTS OF THE INNER CHANNEL. ALL THREE DISTAL GOLD MARKERS WERE SEEN IN POSITION AND UNDAMAGED. THE DISTAL COIL WAS UNDAMAGED, AND ALL DISTAL BONDS WERE INTACT. NO DAMAGE OR DEFORMATION WAS OBSERVED ON THE PROXIMAL SECTION OF THE OUTER CAGE AND INNER CHANNEL. BOTH PROXIMAL MARKERS WERE IN POSITION AND UNDAMAGED. INSPECTION OF THE PROXIMAL COIL SHOWED A COIL OFFSET CONSISTENT WITH HIGH TENSILE OR COMPRESSIVE LOADING BEING APPLIED TO THE DEVICE. THIS OFFSET WOULD NOT AFFECT THE FUNCTIONALITY OF THE DEVICE AND WOULD NOT RESULT IN INCREASED RETRACTION FORCE IN THE INTERMEDIATE CATHETER WHICH HAS AN INNER DIAMETER OF 0.070", SIGNIFICANTLY LARGER THAN THE COIL DIAMETER OF 0.0155". THE PROXIMAL BOND WAS IMPACTED BY REPEATED CLEANING AND DISINFECTION; HOWEVER, THIS MOST LIKELY OCCURRED POST PROCEDURE AND DID NOT AFFECT THE PERFORMANCE OF THE DEVICE. THEREFORE, NO DAMAGE WAS FOUND ON THE EMBOTRAP DEVICE THAT WOULD CAUSE AN INCREASE IN RETRIEVAL FORCE THROUGH AN INTERMEDIATE CATHETER AS REPORTED ON THE EVENT DESCRIPTION. AFTER DISINFECTION, THE DISTAL END OF THE SOFIA INTERMEDIATE CATHETER WAS INSPECTED AT HIGH MAGNIFICATION. THIS INSPECTION SHOWED THAT THE COIL WIRE SUPPORT WHICH IS AN INTEGRAL PART OF THE CATHETER CONSTRUCTION WAS MISSING. GROOVES ON THE INNER SURFACE OF THE CATHETER INDICATE THAT THE COIL WAS IN POSITION DURING MANUFACTURING. AS THE SECTION RETURNED WAS THE PROXIMAL MOST SECTION OF THE CATHETER IT CAN BE ASSUMED THAT THE COIL WAS DISPLACED FROM THE FULL LENGTH OF THE CATHETER. IT IS ALSO POSSIBLE THAT SOME LINER MATERIAL MAY HAVE BEEN DISLODGED. DISPLACED COIL OR LINER MATERIAL IN THE SOFIA COULD CAUSE A SIGNIFICANT OBSTRUCTION TO DEVICE RETRACTION IN THE CATHETER. INSPECTION OF THE WIRE MESH RETURNED WITH THE DEVICE WAS CONDUCTED UNDER HIGH MAGNIFICATION. WHILE HIGHLY DEFORMED, THE SIZE AND SHAPE OF THE WIRE WAS CONSISTENT WITH THE EXPECTED CONDITION OF COIL WIRE DISPLACED FROM THE INNER LUMEN OF THE SOFIA CATHETER. NO OTHER POTENTIAL SOURCES OF THE WIRE WERE IDENTIFIED DURING THE INVESTIGATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED WITH THE CONCOMITANT SOFIA INTERMEDIATE CATHETER SINCE ONLY THE PROXIMAL SECTION OF THE CATHETER WAS RETURNED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE HISTORY RECORDS INDICATE THIS PRODUCT CONFORMED TO MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE CUSTOMER REPORT OF WITHDRAWAL DIFFICULTY THROUGH THE INTERMEDIATE CATHETER COULD NOT BE EVALUATED BECAUSE OF THE DAMAGE PRESENT ON THE RETURNED SOFIA CATHETER WHICH PREVENTED FUNCTIONAL ANALYSIS. INSPECTION OF THE SOFIA PLUS CATHETER SECTION AND THE WIRE MESH RETURNED INDICATED SIGNIFICANT DAMAGE TO THE COIL SUPPORT ALONG THE FULL LENGTH OF THE CATHETER. DISLODGEMENT OF THE COIL SUPPORT FROM THE INNER SURFACE OF THE CATHETER AND POSSIBLE DAMAGE TO THE CATHETER LINER IS HIGHLY LIKELY TO CAUSE SIGNIFICANT RESISTANT TO RETRACTION OF THE EMBOTRAP DEVICE AND CLOT INTO THE INTERMEDIATE CATHETER DURING CLOT RETRIEVAL, CONSISTENT WITH THE EVENT AS REPORTED. THE EMBOTRAP IL DEVICE WAS RETURNED INTACT (I.E. THERE WERE NO MISSING COMPONENTS). THERE WAS NO EVIDENCE OF DAMAGE TO THE EMBOTRAP DEVICE OR EVIDENCE OF MALFUNCTION OF THE EMBOTRAP DEVICE THAT WOULD CAUSE AN INCREASE IN RETRIEVAL FORCE THROUGH AN INTERMEDIATE CATHETER. WITHDRAWAL DIFFICULTY IS A KNOWN POTENTIAL PROCEDURAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. THE IFU CAUTIONS: ¿DO NOT WITHDRAW THE DEVICE AGAINST SIGNIFICANT RESISTANCE. ASSESS THE CAUSE OF RESISTANCE USING FLUOROSCOPY AND IF NECESSARY ADVANCE THE MICROCATHETER OVER THE DEVICE TO RESHEATH OR PARTIALLY RESHEATH TO AID WITHDRAWAL. RESHEATHING A DEVICE WITH CAPTURED CLOT MAY RESULT IN LOSS OF CLOT AND DISTAL EMBOLIZATION.¿ NEITHER THE PRODUCT ANALYSIS NOR THE DEVICE HISTORY REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE COMPLAINT DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL/HANDLING FACTORS, INCLUDING DEVICE MANIPULATION, DEVICE INTERACTION WITH THE SIGNIFICANTLY DAMAGED INTERMEDIATE CATHETER, AND CLOT BURDEN, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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.
(B)(4). SECTION B3 - DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN LATE OCTOBER OF 2018. SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LOT NUMBER OF THE EMBOTRAP II DEVICE IS 17E080AV. THE EVENT OCCURRED SOMETIME IN LATE OCTOBER OF 2018. THE USER ENCOUNTERED HIGH RETRIEVAL FORCE WHILE WITHDRAWING THE EMBOTRAP II THROUGH THE SOFIA INTERMEDIATE CATHETER, BUT THE USER WAS ULTIMATELY ABLE TO REMOVE THE EMBOTRAP II FROM THE SOFIA, OUTSIDE OF THE PATIENT. THE USER APPLIED UNDUE FORCE WHEN THE EMBOTRAP II BECAME STUCK INSIDE OF THE SOFIA CATHETER. AT THIS TIME, THE ENTIRE CATHETER SYSTEM HAD ALREADY BEEN REMOVED FROM THE PATIENT. UPON REMOVAL, THE USER NOTICED THAT PIECES OF THE SOFIA¿S INNER MESH/BRAIDING HAD SEPARATED AND EXITED THE CATHETER. THIS MESH/BRAIDING WILL BE RETURNED WITH THE EMBOTRAP II FOR FURTHER INVESTIGATION. NO VISIBLE PRODUCT DAMAGE WAS NOTED TO THE EMBOTRAP II DEVICE. THERE WAS NO EVIDENCE OF THROMBOEMBOLISM DUE TO THE REPORTED WITHDRAWAL DIFFICULTY. THE PATIENT IS REPORTEDLY DOING FINE. THE PROCEDURAL DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT, AS THE ISSUE OCCURRED FOLLOWING THE PROCEDURE. DETAILS REGARDING THE INTENDED TARGET VESSEL, CLOT CHARACTERISTICS, AND PRE-PROCEDURE TICI SCORE WERE NOT REPORTED. AN UNSPECIFIED 0.021¿ MICROCATHETER WAS USED IN THE CASE. IT IS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED WITHIN THE CATHETER. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT#: (B)(4). UPDATED SECTIONS: DATE REC¿D BY MFR, PMA/510K, IF FOLLOW-UP, WHAT TYPE. CORRECTED SECTIONS: EVENT, LOT#. THE AFFILIATE INDICATED THAT THE CORRECT CATALOG NUMBER IS ET007533. EVENT: (CORRECTED): AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY, THE USER ENCOUNTERED STRONG RESISTANCE WHILE ATTEMPTING TO EXTRACT THE 5X33 EMBOTRAP II (ET007533/UNK LOT) REVASCULARIZATION DEVICE THROUGH THE 6F SOFIA (MICROVENTION) INTERMEDIATE CATHETER. THE USER STOPPED AND REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. POSTOPERATIVELY, THE USER ATTEMPTED TO REMOVE THE EMBOTRAP II PROXIMALLY THROUGH THE SOFIA CATHETER WITH GREAT EFFORT, AND A WIRE MESH BELONGING TO THE SOFIA CATHETER WAS RETRIEVED. THE EMBOTRAP II, ON THE OTHER HAND, WAS UNAFFECTED BY THE MECHANICAL TREATMENT. THE THROMBUS WAS TRAPPED INSIDE OF THE EMBOTRAP II AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 (COMPLETE PERFUSION) WAS ABLE TO BE ACHIEVED ON FIRST PASS. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT # (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO CORRECT THE MANUFACTURER INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
(B)(4). INFORMATION REGARDING PATIENT AGE/DATE OF BIRTH, GENDER, WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT PROVIDED. DATE OF EVENT - THE EVENT OCCURRED IN 2018; HOWEVER, THE MONTH AND DAY WERE NOT REPORTED. THE PRODUCT LOT NUMBER WAS NOT REPORTED. CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: 6F SOFIA (MICROVENTION) INTERMEDIATE CATHETER. INITIAL REPORTER - THE CUSTOMER CONTACT INFORMATION, INCLUDING OCCUPATION, PHONE, AND FAX NUMBER, WAS NOT REPORTED. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY, THE USER ENCOUNTERED STRONG RESISTANCE WHILE ATTEMPTING TO EXTRACT THE 5X33 EMBOTRAP II (ET009533/UNK LOT) REVASCULARIZATION DEVICE THROUGH THE 6F SOFIA (MICROVENTION) INTERMEDIATE CATHETER. THE USER STOPPED AND REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. POSTOPERATIVELY, THE USER ATTEMPTED TO REMOVE THE EMBOTRAP II PROXIMALLY THROUGH THE SOFIA CATHETER WITH GREAT EFFORT, AND A WIRE MESH BELONGING TO THE SOFIA CATHETER WAS RETRIEVED. THE EMBOTRAP II, ON THE OTHER HAND, WAS UNAFFECTED BY THE MECHANICAL TREATMENT. THE THROMBUS WAS TRAPPED INSIDE OF THE EMBOTRAP II AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 (COMPLETE PERFUSION) WAS ABLE TO BE ACHIEVED ON FIRST PASS. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 913134 | EMBOTRAP II 5X33 REVASC. DEV. | CATHETER, THROMBUS RETRIEVER | NRY | NEURAVI LIMITED | 17E080AV | 10886704081326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |