BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 1882085 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04429
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE LOOP OF THE RETURNED DEVICE WAS FRAYED WITH EVIDENCE OF BEING BURNED. THE WIRE LOOP EXTENDED AND RETRACTED PROPERLY. ANALYSIS BY SCANNING ELECTRON MICROSCOPE (SEM) MICROGRAPH CONCLUDED THAT THE LOOP WIRE STRANDS FRAYED OR SEPARATED DUE TO AN EXCESSIVE LOCALIZED HEAT GENERATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON AL GATHERED INFORMATION AND EXTERNAL ANALYSIS RESULTS, IT IS DETERMINED THAT THE FAILURE FOUND WAS MOST LIKELY CAUSED BY AN EXCESSIVE POWER OR HEAT GENERATION. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE (EVENT DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, "THE WIRE CABLE BROKE DURING THE PROCEDURE". NO PART OF THE DEVICE DETACHED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE (EVENT DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, "THE WIRE CABLE BROKE DURING THE PROCEDURE". NO PART OF THE DEVICE DETACHED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562321 0013320452

    Patients

    Seq Age Sex Outcome Treatment
    1