BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM ¿ 88 LARGE DISTAL PLATFORM

    MDR report key: 17561183 · Received August 16, 2023

    Report

    Report Number
    3014590708-2023-00025
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 18, 2023
    Report Date
    August 16, 2023
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    QJP
    UDI-DI
    00812212030368
    PMA / PMN Number
    K231168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOOM 88 CATHETER WAS RETURNED FOR INVESTIGATION. THE CATHETER WAS RECEIVED BROKEN INTO TWO SEGMENTS WITH THE DISTAL SEGMENT STUCK IN A THIRD PARTY RHV. INVESTIGATION DEMONSTRATED COMPLETE SEPARATION OF THE CATHETER SEGMENTS AND SUGGESTED THAT AN AXIAL FORCE WAS APPLIED DURING THE PROCEDURE, BREAKING THE DEVICE INTO TWO SEGMENTS. THE DISTAL SEGMENT BREAK LOCATION OF THE CATHETER WAS JUST PROXIMAL TO THE RHV OPENING AND HAD A SECTION OF COILS WITH MINIMAL STRETCHING OF CATHETER MATERIALS. THE PROXIMAL SEGMENT BREAK LOCATION SHOWED A CLEAN BREAK WITH MINIMAL STRETCHING OF CATHETER MATERIALS AT THE BREAK LOCATION. BASED ON THE INFORMATION PROVIDED AND INVESTIGATION OF THE RETURNED DEVICE, THE BREAK RESULTED FROM INSERTING A LARGER SIZE CATHETER INTO A SMALLER INTERNAL DIAMETER RHV. THE MANUFACTURING RECORDS FOR THE ZOOM 88 WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    A 78-YEAR-OLD MALE WAS TREATED FOR AN OCCLUSION AT THE RIGHT ICA (INTERNAL CAROTID ARTERY) M1 SEGMENT. THE ZOOM 88 ACCESS CATHETER WAS INSERTED INTO AN 8 FRENCH (FR) SHEATH THROUGH A THIRD-PARTY RHV (ROTATING HEMOSTASIS VALVE). THE THIRD-PARTY RHV WAS REPORTED TO HAVE A SMALLER INNER DIAMETER 0.096" (2.44MM)/7.3FR THAN THE ZOOM 88 CATHETER OUTER DIAMETER OF 0.110" (2.8 MM)/8FR. DURING THE INTRODUCTION, THE ZOOM 88 BECAME STUCK IN THE RHV AND THE CATHETER BROKE. THE LOCATION OF THE BREAK IS APPROXIMATELY 15CM FROM THE DISTAL END OF THE ZOOM 88. THE RHV AND ZOOM 88 WERE REMOVED. THE SEPARATED SEGMENT REMAINED INSIDE THE RHV AND DID NOT ENTER THE PATIENT. A BALLOON GUIDE CATHETER WAS USED TO CONTINUE WITH THE PROCEDURE. THE CLOT WAS SUCCESSFULLY REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792736 ZOOM ¿ 88 LARGE DISTAL PLATFORM GUIDE CATHETER QJP IMPERATIVE CARE INC. ICTC088110 F2300502 00812212030368

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male 8FR COOK SHUTTLE 80CM| MERIT MEDICAL RHV (FLO40XR)| Q'APEL WALRUS