BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION¿ SHORT THROW

    MDR report key: 3030187 · Received April 2, 2013

    Report

    Report Number
    3005099803-2013-02380
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF WIRE LOOP FAILED TO RETRACT. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-02380 ADDRESSES THE FIRST SENSATION SNARE, MANUFACTURER REPORT # 3005099803-2013-02381 ADDRESSES THE SECOND SENSATION SNARE, WHILE MANUFACTURER REPORT # 3005099803-2013-02382 ADDRESSES THE THIRD SENSATION SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT THREE SENSATION MEDIUM OVAL SNARES WERE USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE USER ATTEMPTED TO REMOVE A POLYP WITH THE FIRST SENSATION SNARE, THE SNARE LOOP WOULD NOT FULLY RETRACT AROUND THE POLYP. WHEN THE USER TRIED TO OPEN THE SNARE BACK UP, IT WAS NOTED THAT THE LOOP WOULD NOT EXTEND, SO THE DEVICE COULD NOT BE REMOVED FROM THE PATIENT. THE TECH THEN CUT OFF A PIECE OF THE SHEATH NEAR THE HANDLE, WHICH ALLOWED THE SNARE TO FULLY CLOSE AROUND THE POLYP AND ALLOWED THE DEVICE TO BE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THIS HAPPENED WITH ANOTHER TWO SENSATION SNARES. THE PROCEDURE WAS COMPLETED USING THE THREE SENSATION SNARES. IT WAS REPORTED THAT THIS ISSUE HAPPENED WITH THE SAME POLYP AND THAT THE POLYP WAS VERY LARGE AND THICK. 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
    134155 SENSATION¿ SHORT THROW MEDIUM OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562673 14801077

    Patients

    Seq Age Sex Outcome Treatment
    1