BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    072 ASPIRATION SYSTEM

    MDR report key: 19583959 · Received June 21, 2024

    Report

    Report Number
    3015614180-2024-00007
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 26, 2024
    Report Date
    June 19, 2024
    Manufacturer
    Q'APEL MEDICAL INC.
    Product Code
    NRY
    UDI-DI
    00857545008097
    PMA / PMN Number
    K222786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED CATHETER WAS MEASURED FROM THE HUB USING A RULER AND MEASURED ~135CM WHICH IS LONGER THAN THE CATHETER MFG. LENGTH (~132CM). THE TIP WAS VISIBLY MISSING FROM THE CATHETER WITH AN UNWOUND COIL PROTRUDING FROM THE DISTAL END. THE DEVICE WAS OBSERVED TO HAVE SIGNIFICANT FLATTENING OF THE CATHETER AND ELONGATION STARTING AT ~20 CM FROM THE DISTAL END, HOWEVER, THERE WAS NO VISIBLE IMPACT TO THE CATHETER COIL SPACING. USING A MICROSCOPE, NO VISIBLE LINER WAS PRESENT, WHICH DENOTES THAT THE FAILURE WAS WITHIN THE TS 1 SECTION OR DISTAL TIP. BASED ON THE REPORTED COMPLAINT EVENT INTAKE THAT THE DETACHED HIPPO SEGMENT REMAINED WITHIN THE ZOOM RDL CATHETER, THE COMPATIBILITY BETWEEN THE DEVICES HAD REMAINED FOR SOME PORTION AT THE DISTAL END OF THE RDL CATHETER WHEN REMOVAL OF THE DEVICE HAD COMMENCED. THE PHYSICAL EVIDENCE OF THE RETURNED HIPPO CATHETER, WITH VISUAL DEFORMATIONS, IS CONSISTENT WITH THE HIPPO CATHETER BECOMING STUCK DUE TO A KINK IN THE RDL CATHETER THAT PREVENTED THE HIPPO CATHETER DISTAL TIP FROM PASSING THROUGH THAT KINKED POINT. LBS 00807 072 ASPIRATION SYSTEM IFU REV. D WAS REVIEWED. IN THE WARNING SECTION: NEVER ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE DEVICE AGAINST RESISTANCE COULD DISLODGE A CLOT, PERFORATE A VESSEL WALL, OR DAMAGE THE DEVICE. TORQUEING THE CATHETER EXCESSIVELY WHILE KINKED MAY DAMAGE THE DEVICE, RESULTING IN SEPARATION OF THE CATHETER SHAFT. WITHDRAW THE ENTIRE DEVICE (THE DEVICE, MICROCATHETER, AND GUIDEWIRE) IF THE DEVICE IS SEVERELY KINKED.

    Description of Event or Problem · 0

    ASPIRATION SYSTEM (HIPPO) WAS BEING REMOVED/BACKED OUT OF THE ZOOM RDL FOLLOWING ASPIRATION. DR (B)(6) ATTEMPTED TO PASS A ZOOM 71 THROUGH THE ZOOM RDL ON A SECOND PASS AND IT WOULD NOT ADVANCE THROUGH. THE ZOOM RDL AND ZOOM 71 WERE THEN COMPLETELY REMOVED FROM THE BODY IN WHICH IT WAS DISCOVERED THAT THERE WAS A PIECE OF THE HIPPO INSIDE THE RDL TOWARDS THE DISTAL TIP. NO PART OF THE HIPPO TIP REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221540 072 ASPIRATION SYSTEM CATHETER, THROMBUS RETRIEVER NRY Q'APEL MEDICAL INC. FG 00806-02 FG240308A-04 00857545008097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown