BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOTRAP II 5X33 REVASC. DEV.

    MDR report key: 8073429 · Received November 15, 2018

    Report

    Report Number
    3011370111-2018-00106
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 25, 2018
    Report Date
    October 25, 2018
    Manufacturer
    NEURAVI LIMITED
    Product Code
    NRY
    PMA / PMN Number
    K173452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY OF THE INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA), THE 5X33 EMBOTRAP II (ET007533/17H106AV) REVASCULARIZATION DEVICE WAS USED BUT BECAME STRETCHED AND DAMAGED INSIDE OF THE 6F SOFIA PLUS CATHETER. THE EMBOTRAP II WAS ¿SLIGHTLY PRESSED IN AT THE PROXIMAL END¿ AND ¿A METAL WIRE RUNS FROM THE EMBOTRAP TO THE WIRE¿. IT WAS SUSPECTED THAT ¿THE FOUND WIRE BELONGS TO THE SOFIA CATHETER¿. THE EMBOTRAP REPORTEDLY ¿HACKED INTO THE CATHETER BEFORE MOVING IN¿ AND THE REASON IS UNKNOWN. THE EMBOTRAP II AND CATHETER WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A COMPETITOR DEVICE. THE REBAR18 (MEDTRONIC) MICROCATHETER ¿WAS ALREADY PULLED IN ADVANCE¿. THE SURGERY WAS DELAYED 20 MINUTES DUE TO THE EVENT; HOWEVER, THE DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT AND NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. MULTIPLE ATTEMPTS TO OBTAIN FURTHER CLARIFICATION WERE UNSUCCESSFUL. THE SUSPECT DEVICE WAS RETURNED FOR ANALYSIS. THE 6F SOFIA PLUS ASPIRATION CATHETER WAS NOT RETURNED. A VISUAL INSPECTION OF THE EMBOTRAP DEVICE PRIOR TO DISINFECTION WAS COMPLETED. THERE WAS NO DAMAGE TO THE SHAFT COMPONENT; HOWEVER, A THIN WIRE, THAT DID NOT COME FROM THE EMBOTRAP ASSEMBLY, WAS LOOSELY WRAPPED AROUND THE LENGTH OF THE SHAFT AND THE INNER AND OUTER CHANNEL. THE ORIGIN OF THIS WIRE CANNOT BE CONFIRMED AS NO ANCILLARY DEVICES WERE RETURNED FOR EVALUATION. AS THE SHAFT WAS WOUND AROUND ITSELF FOR SHIPPING, THE WIRE ENTANGLED AROUND ITSELF AND COULD NOT BE UNTANGLED. CLOT WAS OBSERVED AT THE PROXIMAL END OF THE OUTER CAGE AND AT THE POINT OF THE DISTAL RADIOPAQUE COIL. POST DISINFECTION, THE DEVICE WAS INSPECTED UNDER HIGH MAGNIFICATION, AND IT WAS OBSERVED THAT THERE WAS NO DAMAGE TO ANY BONDS, THE GOLD MARKERS OR THE INNER/OUTER CAGE. THERE WAS A MINOR OFFSET ON THE PROXIMAL COIL. THIS IS CONSISTENT WITH NORMAL USE AND DOES NOT AFFECT DEVICE FUNCTIONALITY AND DOES NOT POSE A RISK TO THE PATIENT. THERE WAS MINOR DAMAGE ON THE DISTAL TIP; HOWEVER, IT WOULD NOT AFFECT DEVICE FUNCTIONALITY AND OR NOT POSE A RISK TO THE PATIENT. THE DEVICE WAS NOT OTHERWISE STRETCHED OR DAMAGED. FUNCTIONALITY TESTING WAS DEEMED NOT NECESSARY AS THERE WERE NO DEFECTS WITH THE DEVICE THAT WOULD HAVE CAUSE DIFFICULTY TRACKING THROUGH THE CATHETER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. RESISTANCE/FRICTION AND DEVICE DAMAGE ARE KNOWN POTENTIAL FAILURES ASSOCIATED WITH THE USE OF THE EMBOTRAP, 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 USE DAMAGED OR KINKED DEVICES. DO NOT ADVANCE THE DEVICE THROUGH THE MICROCATHETER AGAINST SIGNIFICANT RESISTANCE.¿ ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE MINIMAL INFORMATION PROVIDED AND EVIDENCE PRESENTED BY THE RETURNED SAMPLE; HOWEVER, IT IS POSSIBLE THAT THE FOREIGN WIRE MAY HAVE CONTRIBUTED TO THE RESISTANCE THE PHYSICIAN FELT DURING ADVANCEMENT THROUGH THE CATHETER. THERE IS NO INDICATION THAT THIS COMPLAINT WAS AS A RESULT OF A DEFECT WITH THE EMBOTRAP DEVICE. 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 Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: 6F SOFIA PLUS (MICROVENTION) INTERMEDIATE CATHETER, REBAR18 (MEDTRONIC) MICROCATHETER. 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.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY OF THE INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA), THE 5X33 EMBOTRAP II (ET007533/17H106AV) REVASCULARIZATION DEVICE WAS USED BUT BECAME STRETCHED AND DAMAGED INSIDE OF THE 6F SOFIA PLUS INTERMEDIATE CATHETER. THE EMBOTRAP II WAS ¿SLIGHTLY PRESSED IN AT THE PROXIMAL END¿ AND ¿A METAL WIRE RUNS FROM THE EMBOTRAP TO THE WIRE¿. IT WAS SUSPECTED THAT ¿THE FOUND WIRE BELONGS TO THE SOFIA CATHETER¿. THE EMBOTRAP REPORTEDLY ¿HACKED INTO THE CATHETER BEFORE MOVING IN¿ AND THE REASON IS UNKNOWN. THE EMBOTRAP II AND CATHETER WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A COMPETITOR DEVICE. THE REBAR18 (MEDTRONIC) MICROCATHETER ¿WAS ALREADY PULLED IN ADVANCE¿. THE SURGERY WAS DELAYED 20 MINUTES DUE TO THE EVENT; HOWEVER, THE DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT AND NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS TO OBTAIN FURTHER CLARIFICATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915698 EMBOTRAP II 5X33 REVASC. DEV. CATHETER, THROMBUS RETRIEVER NRY NEURAVI LIMITED 17H106AV

    Patients

    Seq Age Sex Outcome Treatment
    1