BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION? SHORT THROW

    MDR report key: 3120005 · Received May 20, 2013

    Report

    Report Number
    3005099803-2013-03997
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A SENSATION SMALL OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A LARGE PEDUNCULATED POLYP WITH A VERY LONG STALK WAS FOUND IN THE SIGMOID COLON. AS THE SNARE LOOP WAS BEING PLACED OVER THE POLYP HEAD, THE PATIENT VOMITED AND SNEEZED, WHICH FORCED THE POLYP AND SNARE UP THE DESCENDING COLON. WHEN THE POLYP AND SNARE FELL BACK, THE SNARE LOOP HAD TWISTED AND BECOME EMBEDDED IN THE POLYP, WHICH WAS STILL ATTACHED TO THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE SNARE; HOWEVER, WAS UNSUCCESSFUL. THE PATIENT BECAME VERY AGITATED, SO THE SNARE HANDLE WAS CUT OFF, AND THE ENDOSCOPE AND DEVICE SHEATH WERE REMOVED FROM THE PATIENT. THEN THE ENDOSCOPE WAS REINSERTED AND THE PHYSICIAN TRIED TO CUT THE EMBEDDED SNARE WIRES WITH BIOPSY FORCEPS, BUT WAS UNSUCCESSFUL. THE PATIENT THEN WITHDREW CONSENT FOR FURTHER TREATMENT AND WOULD NOT STAY IN THE HOSPITAL. THE PATIENT REPORTEDLY WENT HOME IN STABLE CONDITION WITH THE SNARE WIRE PROTRUDING FROM HER ANUS. THE NEXT DAY, (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL AND THE PHYSICIAN OBSERVED THAT THE WIRES HAD LOOSENED FROM AROUND THE POLYP. THE PHYSICIAN WAS ABLE TO REMOVE THE SNARE FROM AROUND THE POLYP BY GENTLY PULLING THE SNARE WIRE WITHOUT ANY HARM TO THE PATIENT. TWO POLYPS WERE THEN REMOVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN SATISFACTORY CONDITION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS LAST EVENT, AND THERE WAS NO ALLEGED MALFUNCTION OF THE SENSATION SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221952 SENSATION? SHORT THROW SMALL OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562691 15826514

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention