BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 2180052 · Received July 27, 2011

    Report

    Report Number
    3005099803-2011-02397
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    May 20, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED, AND SEVERAL KINKS WERE NOTED ALONG THE WORKING LENGTH. FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE COMPLAINT THAT THE LOOP COULD NOT BE EXTENDED FROM THE SHEATH WAS CONFIRMED; THE DETACHED FLARE PREVENTED DEVICE ACTUATION. SINCE THE COMPLAINANT INDICATED THE DEVICE WAS NOT UNCOILED PRIOR TO USE PER THE DIRECTIONS FOR USE, THE MOST PROBABLE ROOT CAUSE OF THE FAILURES IDENTIFIED IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SHIP HISTORY WAS PERFORMED TO IDENTIFY THE THREE MOST PROBABLE LOTS SHIPPED TO THIS ACCOUNT, AND A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR POLYPECTOMY SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE DOWN THE SCOPE; HOWEVER, THE RESISTANCE WAS NOT SEVERE. ALTHOUGH NO ISSUES WERE REPORTED WITH THE HANDLE FUNCTIONALITY, THE SNARE LOOP WOULD NOT EXTEND FROM THE SHEATH. NO BENDS OR KINKS NOTED ALONG THE PROXIMAL PART OF THE SHEATH, BUT IT WAS REPORTED THAT THE DEVICE WAS NOT COMPLETELY UNCOILED PRIOR TO USE. 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 GOOD. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: FLARE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562301

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR