BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 1860423 · Received October 7, 2010

    Report

    Report Number
    3005099803-2010-04270
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT DISPOSED. IT HAS BEEN RETURNED FOR EVALUATION. A VISUAL EVALUATION OF THE RETURNED DEVICE FOUND A SMALL BEND IN THE LOOP. A FUNCTIONAL EVALUATION FOUND THAT THE EXTENSION AND RETRACTION OF THE LOOP WAS WITHIN SPECIFICATIONS. THE RETURNED DEVICE WAS SUBJECTED TO AN ELECTRICAL RESISTANCE TEST AND WAS WITHIN THE SPECIFICATION OF 20 OHMS (DEVICE READ AT 12.90 OHMS). THE CONDITION OF THE DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT CAUTERY DID NOT WORK; THE COMPLAINT WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION STANDARD OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED WITHIN THE COLON. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SENSATION SNARE DEVICE WAS GOING TO BE USED TO ENSNARE A 2CM POLYP WITHIN THE PATIENT'S COLON. HOWEVER, ONCE THE POLYP ENSNARED THE DEVICE, IT "WOULD NOT BURN" PROPERLY, AS NOT ENOUGH HEAT WAS GENERATED. THEY WERE UNABLE TO REMOVE THE SNARE FROM THE POLYP, AS IT WAS STUCK TO THE POLYP; THEREFORE, THE POLYP WAS "COLD GUILLOTINED." A SECOND LARGER SENSATION SNARE DEVICE WAS USED FOR CAUTERY TO COMPLETE THE REMOVAL OF THE POLYP WITHOUT COMPLICATIONS. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION STANDARD OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED WITHIN THE COLON. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SENSATION SNARE DEVICE WAS GOING TO BE USED TO ENSNARE A 2CM POLYP WITHIN THE PATIENT'S COLON. HOWEVER, ONCE THE POLYP ENSNARED THE DEVICE, IT "WOULD NOT BURN" PROPERLY, AS NOT ENOUGH HEAT WAS GENERATED. THEY WERE UNABLE TO REMOVE THE SNARE FROM THE POLYP, AS IT WAS STUCK TO THE POLYP; THEREFORE, THE POLYP WAS "COLD GUILLOTINED." A SECOND LARGER SENSATION SNARE DEVICE WAS USED FOR CAUTERY TO COMPLETE THE REMOVAL OF THE POLYP WITHOUT COMPLICATIONS. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION 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 M00562671 12875381

    Patients

    Seq Age Sex Outcome Treatment
    1 Other