BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000089-1999-00113

    MDR report key: 256987 · Received December 21, 1999

    Report

    Report Number
    6000089-1999-00113
    Event Type
    Malfunction
    Date Received
    December 21, 1999
    Date of Event
    November 26, 1999
    Report Date
    December 7, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE SHAFT BROKE WHILE ADVANCING THE CATHETER AND WAS REMOVED WITHOUT INCIDENT. NO PT INJURIES OR COMPLICATIONS OCCURRED.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR