BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION¿ SHORT THROW

    MDR report key: 2801056 · Received October 23, 2012

    Report

    Report Number
    3005099803-2012-05063
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    August 16, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. (B)(4) FOR THE REPORTED EVENT: LOOP BURNT. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE LOOP TO BE TWISTED; HOWEVER, THE LOOP WAS CRIMPED TO THE CANNULA AS PER MANUFACTURING SPECIFICATIONS. THE TIP OF THE LOOP WAS ALSO FOUND TO BE BURNT. FUNCTIONAL INSPECTION FOUND THE UNIT EXTENDS AND RETRACTS AS PER MANUFACTURING SPECIFICATIONS. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE LOOP WAS TWISTED; THE COMPLAINT WAS CONFIRMED. IT IS LIKELY THAT ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED AFFECTED THE DEVICE INTEGRITY AND PERFORMANCE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MICRO OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN EXTENDED THE SNARE FROM THE SHEATH, IT WAS NOTED THAT THE LOOP WAS TWISTED NEAR THE TIP: "OTHER SMALL LOOP WAS BEING FORMED AT 2-3MM FROM THE DISTAL TIP BY TWISTED LOOP". NO OTHER DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION MICRO OVAL SNARE. 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 STABLE. INVESTIGATION RESULTS REVEALED THE LOOP WAS BURNT; THEREFORE, THIS IS NOW AN MDR-REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION¿ SHORT THROW SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560321 15338316

    Patients

    Seq Age Sex Outcome Treatment
    1