BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR¿

    MDR report key: 2946073 · Received February 6, 2013

    Report

    Report Number
    3005099803-2013-00703
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SNARE LOOP UNABLE TO CUT. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE SNARE LOOP TO BE TILTED. ELECTRICAL TESTING CONFIRMED THE DEVICE MET THE RESISTANCE SPECIFICATION. THE DEVICE WAS ALSO ABLE TO FULLY EXTEND AND RETRACT. THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE ELECTRICAL RESISTANCE WAS MEASURED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. THE UNIT DID PRESENT A TILTED LOOP, WHICH MAY AFFECT THE ABILITY TO CAPTURE POLYPS; HOWEVER, IT DOES NOT AFFECT THE DEVICE'S ABILITY TO CUT POLYPS, SINCE THE POLYPS ARE CUT WITH ELECTRICAL CURRENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 ON (B)(6) 2013 THAT A CAPTIVATOR LARGE OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE IN THE COLON ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LOOP WAS UNABLE TO CUT; HOWEVER IT WAS REPORTED THAT ENERGY WAS BEING DELIVERED TO THE SNARE AND WAS CONFIRMED THAT CAUTERY WAS WORKING. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THIS 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 OKAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CAPTIVATOR LARGE OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE IN THE COLON ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LOOP WAS UNABLE TO CUT; HOWEVER IT WAS REPORTED THAT ENERGY WAS BEING DELIVERED TO THE SNARE AND WAS CONFIRMED THAT CAUTERY WAS WORKING. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THIS 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 OKAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51186 CAPTIVATOR¿ LARGE OVAL ¿ MEDIUM STIFF FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561311 15322807

    Patients

    Seq Age Sex Outcome Treatment
    1