BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCIMED

    MDR report key: 82988 · Received April 10, 1997

    Report

    Report Number
    82988
    Event Type
    Injury
    Date Received
    April 10, 1997
    Date of Event
    March 27, 1997
    Report Date
    March 28, 1997
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING ROTABLATER PROCEDURE IN THE RCA THE WIRE WAS SHEARED OFF BY THE BURR. THIS WAS NOT IMMEDIATELY APPARENT AND SUBSEQUENT PASS WITH THE BURR PRODUCT PRODUCED A RUPTURE IN THE RCA WALL, CAUSING BLEEDING INTO THE PERICARDIUM. ALTHOUGH BLEEDING WAS CONTROLLED VIA USE OF A PERFUSION BALLOON SURGERY WAS NEEDED FOR RETRIEVAL OF THE DISTAL PORTION OF THE WIRE. CABGX5 AND REPAIR IF RCA LACERATION DONE. DISTAL END OF WIRE RETRIEVED FROM RCA. PRODUCT WALL BE RETAINED BY NMH RISK MGMT DUE TO RISK OF LITIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIMED ROTAWIRE (FLOPPY) DQX BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R