BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 13198027 · Received January 7, 2022

    Report

    Report Number
    3014590708-2022-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 10, 2021
    Report Date
    January 7, 2022
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030191
    PMA / PMN Number
    K211476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOOM 71 CATHETER WAS RETURNED FOR INVESTIGATION. THE RETURNED DEVICE INCLUDES TWO SEGMENTS OF THE ZOOM 71. THERE WERE NO ADDITIONAL ADJUNCTIVE DEVICES RETURNED. THE COMBINED LENGTH OF THE CATHETER MEASURED SHORTER THAN THE REQUIRED SPECIFICATION. THE REVIEW OF THE IMAGES PROVIDED BY THE CUSTOMER INDICATES THAT STRETCHED PORTIONS BETWEEN THE RETURNED DISTAL AND PROXIMAL SEGMENT WERE NOT RETURNED. THE PROXIMAL END OF THE DISTAL SEGMENT IS STRETCHED, WITH NO PROTRUDING COILS OR MATERIALS. THE PROXIMAL SEGMENT IS ALSO STRETCHED ON THE DISTAL END WITH PROTRUDING AND ELONGATED COIL MATERIAL. FOUR KINKS ARE PRESENT ALONG THE PROXIMAL SEGMENT, AND THE CATHETER IS FLATTENED FROM THE DISTAL END OF THE PROXIMAL STRAIN RELIEF. THE ROOT CAUSE OF THE SHAFT SEPARATION WAS DETERMINED TO BE RETRACTION OF CATHETER AGAINST RESISTANCE, SPECIFICALLY DUE TO THE OVERTIGHTENED RHV. PER ZOOM 71 INSTRUCTIONS FOR USE: "DO NOT ADVANCE OR WITHDRAW THE ZOOM CATHETER OR ACCESSORY/ADJUNCTIVE DEVICES AGAINST RESISTANCE WITHOUT CAREFUL ASSESSMENT OF CAUSE UNDER FLUOROSCOPY. IF THE CAUSE CANNOT BE DETERMINED, WITHDRAW ALL DEVICES AS A SINGLE UNIT. EXCESSIVE MANIPULATION AND TORQUING THE DEVICE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE VASCULATURE OR THE DEVICE" AND "DO NOT USE KINKED DEVICES. THE MANUFACTURING RECORDS OF THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. APPROPRIATE TESTING AND INSPECTION WERE COMPLETED TO ENSURE THE DEVICE MET MINIMUM TENSILE SPECIFICATION AND IS KINK RESISTANT. THE DISTAL SECTION UNDERGOES 100% VISUAL INSPECTION AND IS FREE OF VISUAL DEFECTS OR PROTRUSIONS. THE OVERALL LENGTH OF THE DEVICE IS ALSO VERIFIED 100%.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE SECONDARY TO AN AUTOMOBILE ACCIDENT. THE PATIENT WAS ALSO BEING TREATED FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) IN THE TARGET VESSEL FOR THROMBECTOMY (M1). A TOTAL OF THREE PASSES WERE MADE. AFTER THE FIRST PASS, THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING ZOOM 71 THROUGH THE ICI ROTATING HEMOSTASIS VALVE (RHV). THE ENTIRE ZOOM 71 WAS REMOVED AND UPON OBSERVATION ON THE OPERATING TABLE, IT WAS NOTICED THE CATHETER SHAFT HAD FRACTURED. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THIS CATHETER. THE PHYSICIAN COMMENTED THE CATHETER WAS CAUGHT ON THE RHV WHICH WAS POSSIBLY NOT FULLY OPENED WHEN RETRACTING. THE DEVICE WAS REPLACED WITH ANOTHER ZOOM 71 AND SECOND PASS WAS PERFORMED WITHOUT ANY ISSUES. SECOND ZOOM 71 WAS REMOVED, AND THE PHYSICIAN MADE THE THIRD PASS USING ZOOM 55. THE CASE WAS COMPLETED WITH SUCCESSFUL REPERFUSION OF M1 SEGMENT. IN ADDITION, THE PATIENT WAS TREATED FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) WITH ANGIOPLASTY AND STENT. THE PATIENT WAS REPORTED AS STABLE. THERE WERE NO PATIENT SEQUALAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155485 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC071137 F2129501 00812212030191

    Patients

    Seq Age Sex Outcome Treatment
    1 Male INTRACRANIAL STENT.| ZOOM 55.