BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR¿

    MDR report key: 2943334 · Received February 5, 2013

    Report

    Report Number
    3005099803-2013-00570
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    November 19, 2012
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4) FOR THE INVESTIGATION FINDINGS: SHEATH DETACHED. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE FLARE TO BE DETACHED. FUNCTIONAL TESTING OF THE DEVICE COULD NOT BE PERFORMED DUE TO THIS DAMAGE. THE COMPLAINT WAS CONFIRMED; THE DETACHED FLARE PREVENTED LOOP EXTENSION. 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 AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL HEXAGONAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE IN THE LARGE INTESTINE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO EXTEND THE SNARE LOOP; HOWEVER THE LOOP WOULD NOT FULLY EXTEND. THE DEVICE WAS PUT TO THE SIDE AND ANOTHER CAPTIVATOR SNARE WAS USED TO COMPLETE THE PROCEDURE. 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 WAS DETACHED, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48240 CAPTIVATOR¿ SMALL HEXAGONAL - STIFF FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562451 15447424

    Patients

    Seq Age Sex Outcome Treatment
    1