BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 3955817 · Received July 24, 2014

    Report

    Report Number
    3005099803-2014-02575
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PROCEDURE DATE IS UNKNOWN, BUT IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ¿A COUPLE OF WEEKS¿ PRIOR TO THE DATE OF THIS REPORT. REPORTED EVENT: SNARE LOOP SUDDENLY RETRACTED. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL OVAL SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS A DIFFICULTY IN RETRACTING THE DEVICE, AND THEN THE LOOP SUDDENLY RETRACTED. REPORTEDLY, THE LOOP ABRUPTLY CUT THROUGH THE TARGET POLYP AS A RESULT OF THIS ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434180 CAPTIVATOR? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562301 16834744

    Patients

    Seq Age Sex Outcome Treatment
    1