BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 3803078 · Received May 9, 2014

    Report

    Report Number
    3005099803-2014-01954
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OF HANDLE CANNULA 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE DEVICE FOUND THAT THE HANDLE CANNULA 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 WAS CONFIRMED. HOWEVER, THE ROOT CAUSE OF THE HANDLE CANNULA DETACHMENT 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO CAPTIVATOR SMALL HEXAGONAL SNARES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-01953 ADDRESSES THE FIRST DEVICE, WHILE MANUFACTURER REPORT # 3005099803-2014-01954 ADDRESSES THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR SMALL HEXAGONAL SNARES WERE USED DURING A PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE DEVICES WERE BEING USED TO REMOVE LARGE FLAT POLYPS. ONCE THE LOOP OF THE FIRST DEVICE WAS PLACED AROUND THE TARGET POLYP, THE USER ATTEMPTED TO CLOSE THE LOOP AROUND THE POLYP. HOWEVER, THE LOOP WOULD NOT RETRACT BACK TO THE SHEATH. IT WAS REPORTED THAT PART OF THE DEVICE BROKE, BUT CLARIFICATION OF THE DAMAGE WAS NOT PROVIDED. THE SAME ISSUE OCCURRED WITH THE SECOND SNARE; THEREFORE, ANOTHER DEVICE 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 FINE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO CAPTIVATOR SMALL HEXAGONAL SNARES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-01953 ADDRESSES THE FIRST DEVICE, WHILE MANUFACTURER REPORT # 3005099803-2014-01954 ADDRESSES THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPTIVATOR SMALL HEXAGONAL SNARES WERE USED DURING A PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE DEVICES WERE BEING USED TO REMOVE LARGE FLAT POLYPS. ONCE THE LOOP OF THE FIRST DEVICE WAS PLACED AROUND THE TARGET POLYP, THE USER ATTEMPTED TO CLOSE THE LOOP AROUND THE POLYP. HOWEVER, THE LOOP WOULD NOT RETRACT BACK TO THE SHEATH. IT WAS REPORTED THAT PART OF THE DEVICE BROKE, BUT CLARIFICATION OF THE DAMAGE WAS NOT PROVIDED. THE SAME ISSUE OCCURRED WITH THE SECOND SNARE; THEREFORE, ANOTHER DEVICE 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 FINE. 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
    281518 CAPTIVATOR? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562451 16725632

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR