BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 2944331 · Received February 5, 2013

    Report

    Report Number
    3005099803-2013-00590
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    November 13, 2012
    Report Date
    January 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE FLARE WAS DETACHED. THE CONDITION OF THE DEVICE RENDERED FUNCTIONAL TESTING IMPOSSIBLE. THE PRODUCT RETURNED PRESENTED WITH THE FLARE DETACHED WHICH CAUSED THE LOOP TO FAIL TO EXTEND; COMPLAINT CONFIRMED. HOWEVER, THERE IS NOT ENOUGH INFORMATION AND EVIDENCE AVAILABLE TO DETERMINE A ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SMALL OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO OPEN THE SNARE, THE SNARE LOOP FAILED TO EXTEND. NO VISIBLE DAMAGE TO THE DEVICE WAS NOTED. THE PROCEDURE WAS COMPLETED USING A SECOND ROTATABLE SMALL OVAL SNARE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "STABLE." THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; FLARE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48638 ROTATABLE SNARE SMALL OVAL FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561821 15398856

    Patients

    Seq Age Sex Outcome Treatment
    1