BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 4062540 · Received September 5, 2014

    Report

    Report Number
    3005099803-2014-02917
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    January 14, 2014
    Report Date
    August 12, 2014
    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

    INVESTIGATION RESULTS FINDING THE FLARE DETACHED. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED AND THE CATHETER WAS SLIGHTLY KINKED. EVIDENCE OF THE FLARE MANUFACTURING PROCESS WAS PRESENT ON THE CATHETER. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE COMPLAINT WAS CONFIRMED; THE FLARE DETACHMENT PREVENTED THE SNARE LOOP FROM EXTENDING. HOWEVER, THE FLARE DETACHED IS CONTRARY TO WHAT WAS ORIGINALLY REPORTED. THE REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE THE ROOT CAUSE OF THIS COMPLAINT. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LOOP OF THE SNARE DID NOT COME OUT OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE 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 STABLE. INVESTIGATION RESULTS REVEALED THE FLARE DETACHED, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544825 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561830 16033264

    Patients

    Seq Age Sex Outcome Treatment
    1