BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 3851417 · Received June 5, 2014

    Report

    Report Number
    3005099803-2014-02118
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULT OF HANDLE CANNULA DETACHED. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE CANNULA HAS DETACHED. EVIDENCE FROM THE HANDLE ASSEMBLY PROCESS WAS FOUND ON THE HANDLE CANNULA. FUNCTIONAL EVALUATION WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE COMPLAINT THAT THERE WAS FAILURE TO RETRACT WAS CONFIRMED. THE DETACHMENT OF HANDLE CANNULA PREVENTS DEVICE FUNCTIONALITY LIKE LOOP EXTENSION AND LOOP RETRACTION. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS HANDLE CANNULA DETACHMENT ISSUES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX MEDIUM OVAL SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS ABLE TO OPEN AND CLOSED A FEW TIMES. THE SNARE WAS OPENED AND SUDDENLY WAS NOT ABLE TO RETRACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: HANDLE CANNULA DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329253 CAPTIFLEX? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562402 0016500544

    Patients

    Seq Age Sex Outcome Treatment
    1