BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-15421

    MDR report key: 1853898 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15421
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT WHILE REVIEWING A JOURNAL ARTICLE WHICH MENTIONED THE USE OF A BOSTON SCIENTIFIC MICRO-CATHETER SYSTEM, AN ADDITIONAL CASE STUDY OF A (B)(6) MAN THAT EXPERIENCED COMPLICATIONS DURING A PACEMAKER IMPLANT PROCEDURE WAS REFERENCED. IT WAS NOTED THAT THE PHYSICIAN INADVERTENTLY PUNCTURED THE LEFT AUXILIARY ARTERY DURING PACEMAKER INSERTION. POSTOPERATIVELY, THE PATIENT DEVELOPED A HEMATOMA AND INTRAVENOUS CONTRAST-ENHANCED COMPUTED TOMOGRAPHY CONFIRMED A 6 CM AUXILIARY ARTERY PSEUDOANEURYSM. THE PATIENT WAS TREATED WITH A PERCUTANEOUS DIRECT THROMBIN INJECTION. IT IS IMPORTANT TO NOTE THAT PATIENT SPECIFIC INFORMATION, INCLUDING THE MANUFACTURER OF THE PACEMAKER, IS UNKNOWN. AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE ARTICLE, HOWEVER SHE WAS UNABLE TO PROVIDE ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVZ GUIDANT PUERTO RICO BV BRADY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R