BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION POLYPECTOMY SNARE

    MDR report key: 1133737 · Received August 20, 2008

    Report

    Report Number
    3005099803-2008-03093
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FIELD. THE CUSTOMER HAS NOT REPORTED THE LOT INVOLVED. A SHIP HISTORY WAS PERFORMED IN ORDER TO IDENTIFY THE MOST PROBABLE LOTS INVOLVED IN THE REPORTED EVENT AND 3 LOTS TO THE PRODUCT REPORTED. A DHR (DEVICE HISTORY RECORD) REVIEW PERFORMED AND DEVIATIONS WERE NOT FOUND. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POLYPECTOMY PROCEDURE, THE SNARE COMPONENT WAS MISSING. THE LOCATION OF THE POLYP IS UNKNOWN. THE SENSATION MICRO OVAL POLYPECTOMY SNARE WAS INTRODUCED INTO AN UNSPECIFIED ENDOSCOPE AND ADVANCED TO THE POLYP. UPON RELEASING THE DEVICE HANDLE TO OPEN THE SNARE, THE PHYSICIAN NOTED THAT THERE WAS "NO SNARE COMING OUT OF THE CATHETER". THE DEVICE WAS REMOVED FROM THE PATIENT WHERE IT WAS NOTED ON INSPECTION THAT "DESPITE THE HANDLE MOVING THE INTERNAL WIRE, NO SNARE WAS PROTRUDING FROM THE CATHETER". THE PHYSICIAN SUSPECTED THAT A SNARE LOOP HAD NOT BEEN ATTACHED TO THE DEVICE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION POLYPECTOMY SNARE FDI SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC M00562690

    Patients

    Seq Age Sex Outcome Treatment
    1