BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTEL EMBOLECTOMY CATHETER, 3F, 40CM

    MDR report key: 1334406 · Received February 12, 2009

    Report

    Report Number
    2027111-2009-00007
    Event Type
    Other
    Date Received
    February 12, 2009
    Date of Event
    January 8, 2009
    Report Date
    February 9, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE RETURNED CATHETER WAS CONFIRMED DAMAGED. THE SPRING TIP HAD EXTENDED AND WAS SEPARATED FROM THE CATHETER SHAFT. THE DEVICE HISTORY RECORD FOR 1067013 SHOWED NO ABNORMALITIES DURING CONSTRUCTION; ALL CATHETER TEST SAMPLES PASSED THE BALLOON PULL TEST AND THE SPRING TIP PULL FORCE FAR EXCEEDING OUT MINIMUM SPECIFICATIONS. NONE OF THE ABOVE LOT REMAINS IN FINISHED GOODS FOR TESTING. THE CATHETERS ARE DESIGNED IN SUCH A WAY THAT THE PROXIMAL WINDING SLIPS OR THE BALLOON BURST UNDER EXCESSIVE FORCE. THIS PREVENTS THE FORCE FROM BEING APPLIED TO THE CATHETER BODY AND PREVENTS IT FROM BREAKING INSIDE THE PATIENT. THIS ALSO PREVENTS EXCESSIVE FORCE BEING APPLIED TO THE VESSEL ITSELF. THEREFORE, IN ORDER TO BREAK THE CATHETER TIP (SPRING) A CONSIDERABLE AMOUNT OF FORCE MUST BE PLACED ON THE CATHETER. IT IS UNKNOWN UNDER WHAT CONDITIONS AND WHAT TYPE OF INSTRUMENTS WERE USED ALONG WITH THIS CATHETER. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. APPLIED RECOMMENDS THE USE OF A MORE ROBUST CATHETER SUCH AS THE A4534 THROMBECTOMY CATHETER WHEN PERFORMING THROMBECTOMY PROCEDURES.

    Description of Event or Problem · 1

    "THE SURGEON INSERTED THIS CATHETER INTO ULNAR ARTERY OF A PATIENT'S LEFT ARM TO PERFORM THROMBECTOMY. HE FELT THE TIP OF CATHETER TOUCHED SOMETHING. THEN, HE INFLATED THE BALLOON AND TRIED TO RETRIEVE, BUT COULDN'T RETRIEVE THE BALLOON. SO HE DEFLATED THE BALLOON AND TRIED AGAIN TO RETRIEVE THE CATHETER. BUT THE BALLOON WINDING WAS COMPLETELY UNCOILED AND THE BALLOON WAS DISLODGED. HE COULD RETRIEVE THE METAL WINDING, BUT NOT BALLOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTEL EMBOLECTOMY CATHETER, 3F, 40CM EMBOLECTOMY CATHETER DXE APPLIED MEDICAL RESOURCES A4F02 1067013

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization