BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR? II

    MDR report key: 4192665 · Received October 22, 2014

    Report

    Report Number
    3005099803-2014-03405
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K133987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND NO ANOMALIES. ELECTRICAL RESISTANCE TESTING WAS PERFORMED AND RESISTANCE MEASURED AT 7.5 OHMS, WITHIN MANUFACTURING SPECIFICATIONS.THE COMPLAINT WAS NOT CONFIRMED. THE RETURNED DEVICE SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUES, NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. 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. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT A CAPTIVATOR II ROUND SNARE WAS USED IN THE SIGMOID COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS CLOSED AROUND THE TISSUE AND CURRENT WAS APPLIED; HOWEVER, CURRENT WAS NOT BEING DELIVERED TO THE SNARE. THREE ATTEMPTS WERE MADE TO CAUTERIZE THE TISSUE, BUT ALL ATTEMPTS FAILED BECAUSE NO CURRENT WAS BEING DELIVERED. THERE WAS NO VISUAL DAMAGE NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II ROUND SNARE WAS USED IN THE SIGMOID COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS CLOSED AROUND THE TISSUE AND CURRENT WAS APPLIED; HOWEVER, CURRENT WAS NOT BEING DELIVERED TO THE SNARE. THREE ATTEMPTS WERE MADE TO CAUTERIZE THE TISSUE BUT ALL ATTEMPTS FAILED BECAUSE NO CURRENT WAS BEING DELIVERED. THERE WAS NO VISUAL DAMAGE NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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
    672940 CAPTIVATOR? II SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561231 17045327

    Patients

    Seq Age Sex Outcome Treatment
    1