BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR¿

    MDR report key: 2250214 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03101
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    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

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND NO ISSUES, AND THE UNIT EXTENDED AND RETRACTED ACCORDING TO SPECIFICATIONS DURING FUNCTIONAL TESTING. A RESISTANCE TEST WAS PERFORMED, WHICH THE UNIT PASSED (DEVICE MEASURED 11.54 OHMS).THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE SNARE "WOULD NOT CAUTERIZE"; THE COMPLAINT WAS NOT CONFIRMED. THE DEVICE SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUE NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT.A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. 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: SNARE FAILED TO CAUTERIZE. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR POLYPECTOMY SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE SNARE FAILED TO CAUTERIZE EVEN AFTER THE GENERATOR WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR POLYPECTOMY 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 THAT A CAPTIVATOR POLYPECTOMY SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE SNARE FAILED TO CAUTERIZE EVEN AFTER THE GENERATOR WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR POLYPECTOMY 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
    1 CAPTIVATOR¿ SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561311 0014326444

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR