BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE CORD

    MDR report key: 3901583 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02410
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE IS UNKNOWN. THERE WERE TWO PHYSICIANS INVOLVED IN THIS EVENT: DR. (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO TWO DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2014-02404 ADDRESSES THE FIRST DEVICE, WHILE MANUFACTURER REPORT # 3005099803-2014-02410 ADDRESSES THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL SNARE AND AN ACTIVE CORD WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WIRE WAS NOTICED TO BE BENT AND BROKEN AFTER PASSING THROUGH TORTUOUS ANATOMY SEVERAL TIMES. IT WAS REPORTED THAT THE ACTIVE CORD BROKE DURING THE PROCEDURE AS WELL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THERE WERE NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379233 ACTIVE CORD UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00561270

    Patients

    Seq Age Sex Outcome Treatment
    1