BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR OVAL SNARE STANDARD

    MDR report key: 1210711 · Received October 23, 2008

    Report

    Report Number
    3005099803-2008-05481
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SNARE WOULD NOT OPEN AND THE PT WAS SENT FOR SURGERY. THE PHYSICIAN WAS ATTEMPTING TO REMOVE A POLYP IN THE COLON WITH A CAPTIVATOR OVAL SNARE, HOWEVER, IT WAS UNABLE TO CUT THROUGH THE POLYP. THE PHYSICIAN TRIED TO OPEN THE SNARE BUT IT WOULD NOT COME OFF THE POLYP. THE SNARE WAS CUT NEAR THE HANDLE AND THE REMAINING PORTION WAS SECURED TO THE PT WITH TAPE. THE PT WAS THEN SENT TO SURGERY FOR A LAPAROTOMY TO REMOVE THE SNARE. THE PT HAD A BOWEL RESECTION AND THE FOLLOWING DAY THE PT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIVATOR OVAL SNARE STANDARD FDI BOSTON SCIENTIFIC M00562321 11349705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention