BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX¿

    MDR report key: 2943435 · Received February 5, 2013

    Report

    Report Number
    3005099803-2013-00757
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). 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 CAPTIFLEX SMALL OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NURSE EXTENDED THE SNARE LOOP FOR THE PURPOSE OF PERFORMING A POLYPECTOMY INSIDE THE PATIENT'S ASCENDING COLON. WHEN THE NURSE TRIED TO RETRACT THE SNARE, A "GRINDING" WAS FELT AND THE LOOP WOULD NOT RETRACT. THE NURSE TRIED TO RETRACT IT AGAIN, BUT HAD THE SAME ISSUE. THE NURSE DID NOT WANT TO RISK CLOSING THE SNARE BY FORCE AT THE POLYPECTOMY SITE, SO THE SNARE WAS REMOVED FROM THE PATIENT AND FROM SERVICE. THE PROCEDURE WAS COMPLETED USING A SECOND CAPTIFLEX SMALL OVAL SNARE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48906 CAPTIFLEX¿ SMALL OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562422

    Patients

    Seq Age Sex Outcome Treatment
    1