BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000089-1999-00117

    MDR report key: 257232 · Received December 29, 1999

    Report

    Report Number
    6000089-1999-00117
    Event Type
    Injury
    Date Received
    December 29, 1999
    Date of Event
    November 29, 1999
    Report Date
    December 10, 1999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE SHAFT OF THE CATHETER FRACTURED AND WAS RETRIEVED WITH ANOTHER BALLOON. PT STATUS IS LISTED AS "OKAY".

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention
    2
    3