BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 2223565 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02726
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED, AND THE KEY TUBE WAS FOUND OUTSIDE THE DONGLE ASSEMBLY. THE CONDITION OF THE RETURNED DEVICE RENDERED FUNCTIONAL TESTING IMPOSSIBLE. THE COMPLAINT THAT THE SNARE LOOP WOULD NOT EXTEND WAS CONFIRMED; THE DETACHED FLARE PREVENTED DEVICE ACTUATION. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE A ROOT CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02725 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE OVAL SNARES WERE USED DURING REPLACEMENT OF A BILIARY TUBE (DATE PERFORMED UNKNOWN). ACCORDING TO THE COMPLAINANT, NEITHER SNARE LOOP WOULD EXTEND FROM ITS SHEATH. THE PROCEDURE WAS COMPLETED WITH A THIRD ROTATABLE 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 REPORTABLE BASED ON THE INVESTIGATION RESULTS: FLARE DETACHED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02725 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE OVAL SNARES WERE USED DURING REPLACEMENT OF A BILIARY TUBE (DATE PERFORMED UNKNOWN). ACCORDING TO THE COMPLAINANT, NEITHER SNARE LOOP WOULD EXTEND FROM ITS SHEATH. THE PROCEDURE WAS COMPLETED WITH A THIRD ROTATABLE 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 REPORTABLE BASED ON THE INVESTIGATION RESULTS: FLARE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561821 14150850

    Patients

    Seq Age Sex Outcome Treatment
    1