BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 16414815 · Received February 21, 2023

    Report

    Report Number
    3014590708-2023-00003
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    January 22, 2023
    Report Date
    March 16, 2023
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030474
    PMA / PMN Number
    K210996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPERATIVE CARE, INC. RECEIVED THE ZOOM 55 CATHETER INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. INVESTIGATION CONFIRMED THE SHAFT BREAKAGE AND SUGGESTED THAT AN AXIAL FORCE WAS APPLIED DURING THE PROCEDURE, STRETCHING THE SHAFT MATERIALS PRIOR TO THE DEVICE BREAKING. THE MANUFACTURING RECORDS FOR THE ZOOM 55 CATHETER WERE REVIEWED, AND DEMONSTRATED THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED AND DEVICE INVESTIGATION, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT IS RETAINED BY THE HOSPITAL RISK MANAGEMENT DEPARTMENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY. AS THE DEVICE WAS NOT RETURNED THE EXACT ROOT CAUSE OF THE SHAFT BREAKAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    AN 82-YEAR-OLD FEMALE WAS TREATED FOR AN OCCLUSION AT THE M1/M2 SEGMENT. ACCESS WAS OBTAINED WITH A COMPETITOR GUIDE CATHETER AND WAS PARKED AT THE MID-CERVICAL INTERNAL CAROTID ARTERY (ICA). AFTER NOTICING A BEND IN THE MID-CERVICAL, THE PHYSICIAN DID NOT ATTEMPT TO ADVANCE THE GUIDE CATHETER FURTHER. DURING FIRST PASS, THE PHYSICIAN ADVANCED A COMPETITOR ASPIRATION CATHETER AND A STENT RETRIEVER THROUGH THE GUIDE CATHETER, OPENING THE M1 SEGMENT. THE PHYSICIAN THEN REMOVED THE ASPIRATION CATHETER AND STENT RETRIEVER. IN THE SECOND PASS, THE PHYSICIAN ADVANCED A ZOOM 55 ASPIRATION CATHETER OVER A ZOOM 35 ASPIRATION CATHETER TO THE FACE OF THE CLOT AT THE M2 SEGMENT. WHILE PLACING THE ZOOM 35 CATHETER AT THE M2 BRANCH, THE PHYSICIAN FELT RESISTANCE BUT INDICATED IT WAS NOTHING OUT OF THE ORDINARY. THE ZOOM 35 CATHETER WAS REMOVED PRIOR TO ASPIRATION IN M2. ASPIRATION STARTED AND DURING REMOVAL OF THE ZOOM 55, THE PHYSICIAN BELIEVED THE CATHETER SHAFT BROKE AS THERE WAS NO TIP MOVEMENT NOTED. A SNARE WAS USED TO SUCCESSFULLY CAPTURE AND REMOVE THE SEPARATED ZOOM 55 PIECE FROM THE PATIENT. A REPLACEMENT ZOOM 55 CATHETER WAS USED TO SUCCESSFULLY REMOVE THE CLOT AND COMPLETE THE PROCEDURE. TICI 2C SCORE WAS ACHIEVED. THERE WERE NO PATIENT SEQUELAE REPORTED. THE PATIENT PASSED AWAY APPROXIMATELY 2 DAYS AFTER THE PROCEDURE. THE PHYSICIAN ATTRIBUTED THE DEATH TO DETERIORATING PATIENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676413 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC055137 F2233201 00812212030474

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention BENCHMARK BMX 96| EN SNARE,| PENUMBRA (BRAND| RED 62 CATHETER| RED 72 CATHETER| SOFIA CATHETER| SOLITAIRE STENT RETRIEVER (MEDTRONIC)| VELOCITY MICROCATHETER| ZOOM 35| ZOOM 55