BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 21495853 · Received February 28, 2025

    Report

    Report Number
    3014590708-2025-00005
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    January 30, 2025
    Report Date
    February 28, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    PMA / PMN Number
    K211476
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A ZOOM 71, ZOOM 55 AND ZOOM 88 WERE RETURNED FOR INVESTIGATION. THE REPORTED SEPARATED DISTAL SEGMENT OF THE ZOOM 71 WAS NOT RETURNED FOR INVESTIGATION. THE PROXIMAL SEGMENT OF THE ZOOM 71 WAS RETURNED AND FOUND CATHETER SHAFT MATERIALS KINKED AND STRETCHED. THE INVESTIGATION OF THE RETURNED ZOOM 71 DEMONSTRATED DAMAGE WHICH SUGGESTS AN AXIAL FORCE WAS APPLIED DURING THE PROCEDURE RESULTING IN STRETCHING OF SHAFT MATERIALS PRIOR TO THE DEVICE BREAKING. VISUAL INSPECTION OF THE RETURNED ZOOM 88 CONFIRMED A KINK ON THE MID-SHAFT OF THE CATHETER. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHEN THE KINK OCCURRED. THE DISTAL SECTION OF THE RETURNED ZOOM 55 WAS OBSERVED TO BE DAMAGED WITH MULTIPLE KINKS, DAMAGE TO THE MARKERBAND, AND EVIDENCE OF STRETCHED CATHETER MATERIALS. BASED ON THE COMPLAINT INFORMATION PROVIDED, THE EXACT ROOT CAUSE FOR THE REPORTED SHAFT BREAK ON THE ZOOM 71 COULD NOT BE DETERMINED. PRESENCE OF ATHEROSCLEROSIS (ICAD) IN THE CAROTID ARTERY MAY HAVE CONTRIBUTED TO RESISTANCE, DAMAGE, AND THE SHAFT BREAK OF THE ZOOM 71 DURING ITS REMOVAL. THE KINKED ZOOM 88 MAY HAVE FURTHER CONTRIBUTED TO RESISTANCE, HOWEVER IT WAS UNCLEAR IF THE KINK OCCURRED PRIOR TO OR AFTER USE WITH THE ZOOM 71. THE LOT NUMBER FOR THE ZOOM 71 COMPLAINT DEVICE WAS REPORTED AS UNKNOWN BY THE SITE. THE MANUFACTURING RECORDS FOR ALL FINISHED GOODS LOTS SHIPPED 6-MONTHS PRIOR TO THE EVENT DATE WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE LEFT M1 SEGMENT. ACCESS WAS OBTAINED WITH A ZOOM 88 GUIDE CATHETER AND A THIRD-PARTY ACCESS CATHETER. THE ANATOMY WAS NOTED AS NOT BEING TERRIBLY TORTUOUS. THE PATIENT REPORTEDLY HAD ATHEROSCLEROSIS (ICAD). NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE ZOOM 88. THE ZOOM 88 WAS PARKED AT CERVICAL ICA. WHILE ADVANCING THE ZOOM 71, NO RESISTANCE WAS FELT UNTIL IT REACHED THE CAROTID. THE PHYSICIAN ASSUMED THAT THE ZOOM 71 HAD GOTTEN HUNG UP ON THE ATHEROSCLEROSIS DURING ADVANCEMENT. THE DECISION WAS MADE TO REMOVE THE ZOOM 71 FROM THE PATIENT. DURING REMOVAL RESISTANCE WAS ENCOUNTERED. IMAGING WAS PERFORMED AND SHOWED A BROKEN DISTAL SEGMENT OF THE ZOOM 71 IN THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN SEGMENT BUT WERE UNSUCCESSFUL. RETRIEVAL ATTEMPTS PUSHED THE BROKEN PIECE FURTHER OUT OF THE M1 AND INTO A SMALLER DISTAL VESSEL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A ZOOM 55 BUT ALSO MET RESISTANCE. THE M1 WAS CLEARED OF THE OCCLUSION AND THE PATIENT WAS REPORTED TO BE STABLE POST-PROCEDURE. IT WAS DETERMINED THAT THE DISTAL SEGMENT OF THE ZOOM 71 WAS NOT FLOW LIMITING AND THE DECISION WAS MADE TO LEAVE IT IN THE PATIENT. THE PHYSICIAN BELIEVED THERE WAS A KINK ON THE ZOOM 88. IT IS UNKNOWN WHEN THE ZOOM 88 HAD KINKED AND WAS NOT OBSERVED ON THE IMAGING. THE ZOOM 55 USED IN THE CASE ALSO SHOWED DAMAGE TO THE DISTAL PORTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521639 ZOOM REPERFUSION CATHETER ZOOM REPERFUSION CATHETER NRY IMPERATIVE CARE INC. ICRC071137 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SIM ACCESS CATHETER.| SNARE (BRAND UNKNOWN).| STENT RETRIEVER (BRAND UNKNOWN).| TIGER STENT RETRIEVER.| ZOOM 45.| ZOOM 55.| ZOOM 88.