BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CATHETER

    MDR report key: 1873924 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17771
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    December 10, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PRODUCTS RETURNED CONSISTED OF AN 8 FRENCH, 68 CENTIMETER (CM) ACUITY DELIVERY SYSTEM. THE CUTTING DEVICE WAS NOT RETURNED. VISUAL INSPECTION NOTED THE HUB HAD BEEN UNSNAPPED AND WAS IN TWO PIECES TO ALLOW THE SHAFT TO BE SLICED (BY DESIGN). THE SHAFT WAS IN TWO PIECES. THE PROXIMAL END OF THE SHAFT WAS CUT LONGITUDINALLY BY THE CUTTING DEVICE. THE DISTAL END OF THE SHAFT WAS NOT SLICED. IT WAS SEPARATED (BROKEN) APPROXIMATELY 34.5 CM FROM THE PROXIMAL END OF THE DELIVERY SYSTEM. THE REMAINING 39 CM OF THE DISTAL SECTION WAS NOT SLICED INDICATING AN ISSUE WITH THE CUTTING TECHNIQUE. THIS TYPE OF SHAFT BREAK IS CONSISTENT WITH AN INCORRECT CUTTING TECHNIQUE, AS STATED IN THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO CUT AWAY THIS BREAK-AWAY INNER GUIDING CATHETER, A PIECE PEELED OFF IN THE PATIENT. THE LEAD HAD TO BE REMOVED TO GET THE CATHETER OUT. IT WAS LATER CONFIRMED THAT ALL PIECES OF THE CATHETER WERE ABLE TO BE REMOVED FROM THE PATIENT. THE PHYSICIAN THEN USED AN 8 FRENCH OUTER CATHETER TO SUCCESSFULLY IMPLANT THE LEAD. IT WAS ALSO LATER NOTED THAT IN OBSERVING THE BREAKING AND CUTTING, IT MAY HAVE BEEN A CUTTING TECHNIQUE AND NOT AN ISSUE WITH THE CATHETER. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    THE CATHETER WAS LATER RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CATHETER GUIDE CATHETER DYB GUIDANT PUERTO RICO BV 7065

    Patients

    Seq Age Sex Outcome Treatment
    1