BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCA-EX ATHERECTOMY CATHETER

    MDR report key: 115546 · Received August 21, 1997

    Report

    Report Number
    2024168-1997-00117
    Event Type
    Malfunction
    Date Received
    August 21, 1997
    Date of Event
    July 24, 1997
    Report Date
    July 24, 1997
    Manufacturer
    GUIDANT ACS/DVI
    Product Code
    MCX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PERFORMING AN ATHERECTOMY PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE UNIT WAS REMOVED PARTIALLY INFLATED AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE REPORTEDLY WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCA-EX ATHERECTOMY CATHETER CORONARY ATHERECTOMY CATHETER MCX GUIDANT ACS/DVI NA 7011351

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other TREATMENT OF EVENT: UNK