BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 1935858 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05282
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4): ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE CANNULA HAD DETACHED, WHICH PREVENTED THE LOOP FROM EXTENDING AND RETRACTING. CRIMPING MARKS (FROM THE ATTACHMENT OF THE CABLE TO THE HANDLE CANNULA DURING MANUFACTURING) WERE REVIEWED AND WERE FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE SNARE LOOP WAS BROKEN; THE COMPLAINT WAS NOT CONFIRMED. THE FAILURE FOUND IS LIKELY DUE TO A LOSS OF CONNECTION BETWEEN THE HANDLE AND HANDLE CANNULA DURING THE MANUFACTURING PROCESS, AND A CORRECTION HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE. 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

    AS THE BATCH NUMBER FOR THIS DEVICE WAS UNKNOWN, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED AND THE COMPLAINT DATABASE COULD NOT BE SEARCHED FOR OTHER COMPLAINTS ON THE SAME BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MICRO OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE WIRE IN THE SNARE LOOP BROKE DURING THE PROCEDURE. NO PART OF THE SNARE DETACHED OR FELL INTO THE PATIENT, AND NO PROBLEMS WERE ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION MICRO OVAL 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 SENSATION MICRO OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE WIRE IN THE SNARE LOOP BROKE DURING THE PROCEDURE. NO PART OF THE SNARE DETACHED OR FELL INTO THE PATIENT, AND NO PROBLEMS WERE ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION MICRO OVAL 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 SENSATION MICRO OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE WIRE IN THE SNARE LOOP BROKE DURING THE PROCEDURE. NO PART OF THE SNARE DETACHED OR FELL INTO THE PATIENT, AND NO PROBLEMS WERE ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION MICRO OVAL 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 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562693

    Patients

    Seq Age Sex Outcome Treatment
    1