BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX¿

    MDR report key: 3030472 · Received April 2, 2013

    Report

    Report Number
    3005099803-2013-02113
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 18, 2013
    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 RESULTS - THE COMPLAINT DEVICE WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE HANDLE CANNULA WAS DETACHED FROM THE HANDLE. THE ACTIVE CORD INSERT AND THE ACTIVE CORD CONNECTOR WERE MEASURED AND BOTH OF THEM WERE FOUND TO BE WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED DEVICE RENDERED FUNCTIONAL TESTING IMPOSSIBLE. THE COMPLAINT WAS CONFIRMED; THE DETACHED HANDLE CANNULA PREVENTED LOOP RETRACTION. IMPROPER ASSEMBLY OF THE CANNULA AND HANDLE LIKELY CAUSED THE CANNULA TO DETACH DURING USE; THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS FAILURE IS MANUFACTURING. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF WIRE LOOP FAILED TO RETRACT. 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 ON (B)(4) 2013 THAT A CAPTIFLEX EXTRA SMALL OVAL SNARES WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS USED TO REMOVE ONE POLYP SUCCESSFULLY. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE A SECOND POLYP, THE DEVICE HANDLE WOULD NOT CLOSE AND THE SNARE LOOP FAILED TO RETRACT OVER THE POLYP. THE DEVICE WAS REMOVED FROM THE PATIENT AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CAPTIFLEX EXTRA SMALL OVAL SNARES WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS USED TO REMOVE ONE POLYP SUCCESSFULLY. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE A SECOND POLYP, THE DEVICE HANDLE WOULD NOT CLOSE AND THE SNARE LOOP FAILED TO RETRACT OVER THE POLYP. THE DEVICE WAS REMOVED FROM THE PATIENT AND 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134764 CAPTIFLEX¿ EXTRA SMALL OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562471 15801176

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR