BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 3840468 · Received May 30, 2014

    Report

    Report Number
    3005099803-2014-02073
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND SHAVINGS INSIDE THE CATHETER, AND THE HANDLE CANNULA WAS BENT AND DETACHED. THERE WERE MARKS NOTED ON THE HANDLE CANNULA FROM THE HANDLE ASSEMBLY PROCESS. THE HANDLE CANNULA WAS INSPECTED UNDER MAGNIFICATION, AND EVIDENCE OF SHARP EDGES WAS FOUND. THE HANDLE CANNULA LIKELY SCRAPED THE INNER SHEATH DURING ACTUATION, CAUSING THE SHAVINGS. CONTINUED ACTUATION AGAINST THE RESISTANCE CAUSED BY THE CANNULA/SHEATH INTERACTION LIKELY CAUSED THE HANDLE CANNULA TO BEND. THE COMPLAINT THAT THE HANDLE CANNULA WAS BENT WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THE SHARP EDGES ON THE HANDLE CANNULA IS SUPPLIER MANUFACTURE, AND CORRECTIVE ACTION HAS BEEN REQUESTED. HOWEVER, THE ROOT CAUSE OF THE HANDLE CANNULA DETACHMENT COULD NOT BE DETERMINED. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL OVAL SNARE WAS USED IN THE TRANSVERSE COLON DURING A POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE METAL ROD IN THE HANDLE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SMALL OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; HANDLE CANNULA DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319416 CAPTIVATOR? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562301 16500541

    Patients

    Seq Age Sex Outcome Treatment
    1