BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 2896678 · Received January 4, 2013

    Report

    Report Number
    3005099803-2012-06329
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 20, 2012
    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

    THE INVESTIGATION FINDINGS: FLARE DETACHED. A VISUAL EXAMINATION OF THE DEVICE FOUND THE FLARE TO BE DETACHED. THE CONDITION OF THE DEVICE RENDERED FUNCTIONAL TESTING IMPOSSIBLE. THE COMPLAINT WAS CONFIRMED. THE FAILURE OF FLARE DETACHED WOULD IMPEDE THE SNARE LOOP FROM BEING ABLE TO EXTEND. HOWEVER, THERE IS NOT ENOUGH INFORMATION AND EVIDENCE AVAILABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT. 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 MEDIUM OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED IN THE COLON. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE NURSE CHECKED THE FUNCTION OF THE DEVICE, IT WAS NOTED THAT THE SNARE DID NOT EXTEND SMOOTHLY. THE PROCEDURE WAS COMPLETED USING A SECOND ROTATABLE MEDIUM OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD FOLLOWING THE PROCEDURE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: FLARE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4542 ROTATABLE SNARE MEDIUM OVAL FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 0014185723

    Patients

    Seq Age Sex Outcome Treatment
    1