BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERPA BALANCED 6F GUIDE CATHETER

    MDR report key: 2801969 · Received October 23, 2012

    Report

    Report Number
    1220452-2012-00058
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 3, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDTORNIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K042489
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE USED IN CASE WAS EVALUATED. VISUAL EXAMINATION PERFORMED. CONCLUSION: THE ACTUAL DEVICE USED IN THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE RETURNED GUIDE CATHETER REVEALED THAT THE SHAFT WAS SEPARATED INTO TWO PIECES. THE HUBBED SECTION OF THE GUIDE CATHETER MEASURES 40CM IN LENGTH. THE DISTAL SECTION OF THE CATHETER MEASURES APPROXIMATELY 59CM IN LENGTH. CLOSE VISUAL EXAMINATION OF THE SEPARATION OF THE GUIDE CATHETER REVEALED THAT THE SHAFT WAS EXCESSIVELY TORQUED AND TWISTED BEYOND THE DESIGN EXPECTATION. THE GUIDE CATHETER PASSES ALL RELEVANT PHYSICAL MEASUREMENTS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES WITHIN THE MANUFACTURING PROCESS. THE EVENT IS CONFIRMED FOR SEPARATION OF THE GUIDE CATHETER SHAFT. THE GUIDE CATHETER WAS TWISTED AND TORQUED BEYOND DESIGN EXPECTATION. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. ONCE THE EVALUATION IS COMPLETED A FOLLOW- UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THE 6FGUIDE CATHETER SHAFT BROKE DURING USE. THE PATIENT HAD TO HAVE THE DISTAL END OF THE CATHETER REMOVED USING INTERVENTIONAL RADIOLOGY. THE PATIENT IS STABLE WITH NO COMPLICATIONS AS A RESULT OF THE GUIDE CATHETER ISSUE. IT WAS REPORTED THE ANATOMY WAS VERY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERPA BALANCED 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTORNIC, INC 0006347078

    Patients

    Seq Age Sex Outcome Treatment
    1