BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY CATHETER

    MDR report key: 2172959 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10469
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    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

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT WAS DISCARDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD DISPLAYED INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. INSULATION DAMAGE WAS ASSUMED. AN X-RAY WAS PERFORMED, CONFIRMING THE LV LEAD TO BE FRACTURED. IT WAS THOUGHT TO BE A RESULT OF A CLAVICULAR CRUSH. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS EXTRACTED SUCCESSFULLY. A VESSEL DISSECTION OCCURRED AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS WITH TWO DIFFERENT LV LEADS AND WHILE USING A BALLOON CATHETER AND THIS INNER GUIDING CATHETER. THE DEVICE WAS REPROGRAMMED TO RIGHT VENTRICLE (RV) ONLY AND THE PROCEDURE WAS ABANDONED. A REVISION PROCEDURE WAS SCHEDULED TO IMPLANT AN LV LEAD AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CATHETER GUIDE CATHETER DYB GUIDANT PUERTO RICO BV 7064

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R 1861| 4592| (B)(4)| N119| 4543| 0157