BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION? SHORT THROW

    MDR report key: 3092631 · Received May 3, 2013

    Report

    Report Number
    3005099803-2013-03129
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE COMPLAINT DEVICE WAS VISUALLY INSPECTED AND NO ISSUES WERE NOTED. THE UNIT WAS ABLE TO EXTEND AND RETRACT ACCORDING TO SPECIFICATIONS. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED; THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF LOOP EMBEDDED IN POLYP. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT A SENSATION MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SNARE LOOP WAS POSITIONED AROUND THE POLYP, THE LOOP COULD ONLY BE RETRACTED SLIGHTLY. THE NURSE THEN ATTEMPTED TO REOPEN THE LOOP, BUT IT COULD NOT BE EXTENDED AND IT WAS CONSEQUENTLY STUCK ON THE POLYP. THE NURSE MANIPULATED THE DEVICE AND WAS FINALLY ABLE TO EXTEND THE LOOP. THEN THE NURSE RETRACTED THE LOOP AROUND THE POLYP AND WAS ABLE TO REMOVE THE POLYP WITHOUT ISSUE. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE CAUTERY. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER SENSATION SNARE WAS USED TO COMPLETE THE PROCEDURE. 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 ON (B)(4) 2013 THAT A SENSATION MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SNARE LOOP WAS POSITIONED AROUND THE POLYP, THE LOOP COULD ONLY BE RETRACTED SLIGHTLY. THE NURSE THEN ATTEMPTED TO REOPEN THE LOOP, BUT IT COULD NOT BE EXTENDED AND IT WAS CONSEQUENTLY STUCK ON THE POLYP. THE NURSE MANIPULATED THE DEVICE AND WAS FINALLY ABLE TO EXTEND THE LOOP. THEN THE NURSE RETRACTED THE LOOP AROUND THE POLYP AND WAS ABLE TO REMOVE THE POLYP WITHOUT ISSUE. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE CAUTERY. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER SENSATION SNARE WAS USED TO COMPLETE THE PROCEDURE. 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
    194217 SENSATION? SHORT THROW MEDIUM OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562673 14150846

    Patients

    Seq Age Sex Outcome Treatment
    1