BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 3542849 · Received December 30, 2013

    Report

    Report Number
    3005099803-2013-14843
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Report Date
    December 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) LOOP FAILED TO TRANSMIT CURRENT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 RETURNED DEVICE DID NOT FIND ANY VISUAL ANOMALY. ELECTRICAL TESTING WAS PERFORMED AND THE RESISTANCE WAS FOUND TO BE WITHIN SPECIFICATIONS. THE COMPLAINT THAT THE SNARE FAILED TO DELIVER ENERGY WAS NOT CONFIRMED. THE DEVICE RETURNED SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUE, NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT. 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 DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-14843 ADDRESSES THE FIRST CAPTIVATOR MEDIUM OVAL SNARE, AND MANUFACTURER REPORT # 3005099803-2013-14844 ADDRESSES THE SECOND CAPTIVATOR MEDIUM OVAL SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL SNARE WAS USED IN THE COLON DURING A COLONOSCOPY AND POLYPECTOMY PROCEDURE. IT WAS REPORTED THAT THE FIRST SNARE WAS UNABLE TO TRANSMIT CURRENT. THE SAME ISSUE OCCURRED WITH THE SECOND SNARE. THE PROCEDURE WAS COMPLETED BY USING A THIRD CAPTIVATOR MEDIUM OVAL 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 GOOD.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-14843 ADDRESSES THE FIRST CAPTIVATOR MEDIUM OVAL SNARE, AND MANUFACTURER REPORT # 3005099803-2013-14844 ADDRESSES THE SECOND CAPTIVATOR MEDIUM OVAL SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL SNARE WAS USED IN THE COLON DURING A COLONOSCOPY AND POLYPECTOMY PROCEDURE. IT WAS REPORTED THAT THE FIRST SNARE WAS UNABLE TO TRANSMIT CURRENT. THE SAME ISSUE OCCURRED WITH THE SECOND SNARE. THE PROCEDURE WAS COMPLETED BY USING A THIRD CAPTIVATOR MEDIUM OVAL 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679228 CAPTIVATOR? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562321 0016013485

    Patients

    Seq Age Sex Outcome Treatment
    1