BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCA-EX ATHERECTOMY CATHETER

    MDR report key: 120030 · Received September 10, 1997

    Report

    Report Number
    2024168-1997-00126
    Event Type
    Malfunction
    Date Received
    September 10, 1997
    Date of Event
    July 9, 1997
    Report Date
    August 11, 1997
    Manufacturer
    GUIDANT ACS/DVI
    Product Code
    MCX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DCA PROCEDURE, AFTER THE BALLOON WAS INFLATED THE CUTTER ADVANCED, EVEN THOUGH THE ACTIVATION CONTROL LEVER HAD NOT BEEN ADVANCED. WHEN AN ATTEMPT WAS MADE TO WITHDRAW THE CATHETER, THE BALLOON WOULD NOT DEFLATE. THE DEVICE WAS REMOVED WITH THE BALLOON INFLATED. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN