BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO POLYPROPYLENE SUTURE

    MDR report key: 1902925 · Received November 12, 2010

    Report

    Report Number
    MW5018219
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC CORPORATE HEADQUARTERS
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CAPIO SUTURE PLACED ON THE RIGHT SIDE JUST ANTERIOR TO THE ISCHIAL SPINE WAS COMPLICATED BY THE FACT THAT THE SMALL BULLET-TIPPED NEEDLE SHEARED OFF THE SUTURE AND WAS BURIED IN THE ARCUS AT THAT POINT. ATTEMPT WAS MADE TO TRY TO LOCATE THE NEEDLE TO REMOVE, BUT THIS COULD NOT BE REMOVED SINCE THE NEEDLE WAS CLEARLY EMBEDDED IN THE SOFT TISSUE MUCH LIKE A SMALL BONE ANCHOR. IT WAS FELT THAT THIS WOULD BE OF NO CONSEQUENCE AND IT WAS LEFT IN PLACE. PHYSICIAN SAID IT WAS LIKE LEAVING A LIGAMENT CLIP IN. WOULD CAUSE MORE HARM TO TRY TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO POLYPROPYLENE SUTURE CAPIO SUTURE MFJ BOSTON SCIENTIFIC CORPORATE HEADQUARTERS 02D0900771

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR