BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3901027 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02290
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 4, 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

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE CANNULA IS BENT AND THE CATHETER IS SLIGHTLY KINKED. THE FLARE WAS DETACHED FROM THE CATHETER, AND THE CATHETER HAS MARKS FROM THE FLARE PROCESS PERFORMED DURING MANUFACTURING. THE WIRE AND LOOP WERE INSPECTED AND BOTH WERE FOUND NOT BROKEN. FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE COMPLAINT WAS CONFIRMED, THE DEVICE IS INOPERABLE SINCE THE FLARE IS DETACHED. IN ADDITION, THE DEVICE WAS NOT USED FOR THE INTENDED USE OF POLYP AND TISSUE REMOVAL FROM THE GASTROINTESTINAL TRACT. HOWEVER, REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE FOR THIS EVENT. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED EVENT OF WIRE BROKE. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SMALL OVAL SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN INTENDED TO USE THIS DEVICE TO REMOVE A BILE DUCT TUBE. DURING THE PROCEDURE, WHEN ATTEMPTING TO ACTUATE THE SNARE, SEVERE RESISTANCE WAS FELT AND THE SNARE FAILED TO EXTEND OUT OF THE SHEATH. THE SEVERE RESISTANCE THEN SUDDENLY RELEASED AND THE SNARE WIRE FELT LIKE IT WAS ¿CUT¿. THEY REMOVED THE SNARE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE SMALL OVAL SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN INTENDED TO USE THIS DEVICE TO REMOVE A BILE DUCT TUBE. DURING THE PROCEDURE, WHEN ATTEMPTING TO ACTUATE THE SNARE, SEVERE RESISTANCE WAS FELT AND THE SNARE FAILED TO EXTEND OUT OF THE SHEATH. THE SEVERE RESISTANCE THEN SUDDENLY RELEASED AND THE SNARE WIRE FELT LIKE IT WAS ¿CUT.¿ THEY REMOVED THE SNARE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380966 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561821

    Patients

    Seq Age Sex Outcome Treatment
    1