BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CATHETER

    MDR report key: 3053117 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04416
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    June 10, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED THE HUB WAS BROKEN APART. IN ADDITION, THE ENTIRE LENGTH OF THE SHAFT HAD BEEN CUT. THERE WAS A COMPLETE SEPARATION OF THE SHAFT 5.5 CM FROM THE STRAIN RELIEF AND A PARTIAL SHAFT SEPARATION 8 CM FROM THE FRACTURE SURFACE. MAGNIFIED INSPECTION CONFIRMED THAT THE FRACTURED END OF THE SHAFT WAS JAGGED, CONSISTENT WITH DUCTILE DEFORMATION DUE TO TENSILE OVERLOAD. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS BREAK AWAY GUIDING CATHETER BECAME STUCK DURING THE TEARING AWAY AND BROKE APPROXIMATELY EIGHT CM AWAY FROM THE VALVE PORTION OF THE CATHETER. THE CATHETER WAS TORN AWAY AND THE LEFT VENTRICULAR LEAD REMAINED IMPLANTED IN POSITION AND THE PROCEDURE WAS SUCCESSFUL. THIS GUIDING CATHETER WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156267 ACUITY CATHETER GUIDE CATHETER DYB EXTERNAL MANUFACTURER 7067

    Patients

    Seq Age Sex Outcome Treatment
    1