BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3812253 · Received May 15, 2014

    Report

    Report Number
    3005099803-2014-02002
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 21, 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: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED. THE PROXIMAL SECTION OF THE WIRE WAS KINKED IN TWO PLACES, AND THE CATHETER WAS ALSO KINKED AT ONE OF THESE LOCATIONS. EVIDENCE OF FLARE PROCESS WAS PRESENT ON THE CATHETER. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE COMPLAINT THAT THE FLARE DETACHED WAS CONFIRMED. THE EVIDENCE OF THE FLARE PROCESS INDICATES THAT THE CATHETER WAS INITIALLY ATTACHED TO THE HANDLE. MANIPULATION OF THE DEVICE COULD HAVE CAUSED THE KINKS IN THE WIRE. THE KINKS LIKELY CAUSED FRICTION AND RESISTANCE UPON DEVICE ACTUATION, ULTIMATELY RESULTING IN FLARE DETACHMENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS REPORTED EVENT IS OPERATIONAL CONTEXT. 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.

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. REPORTED EVENT OF FLARE DETACHED. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MEDIUM SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE SNARE WAS INSERTED IN THE ENDOSCOPE, THE PHYSICIAN ATTEMPTED TO RETRACT THE SNARE BUT FAILED. THE PLASTIC SHEATH NEAR THE HANDLE WAS SEPARATED INTO TWO EXPOSING THE WIRE INSIDE THE SHEATH. IT WAS REPORTED THAT THE SHEATH SEEMED TO HAVE BEEN TORN BEFORE THE DEVICE WAS UNPACKED. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL MEDIUM SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE SNARE WAS INSERTED IN THE ENDOSCOPE, THE PHYSICIAN ATTEMPTED TO RETRACT THE SNARE BUT FAILED. THE PLASTIC SHEATH NEAR THE HANDLE WAS SEPARATED INTO TWO EXPOSING THE WIRE INSIDE THE SHEATH. IT WAS REPORTED THAT THE SHEATH SEEMED TO HAVE BEEN TORN BEFORE THE DEVICE WAS UNPACKED. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291607 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 0016634162

    Patients

    Seq Age Sex Outcome Treatment
    1