BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000089-1999-00114

    MDR report key: 257237 · Received December 29, 1999

    Report

    Report Number
    6000089-1999-00114
    Event Type
    Injury
    Date Received
    December 29, 1999
    Date of Event
    November 24, 1999
    Report Date
    December 7, 1999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE BALLOON RUPTURED AND CAUSED A SPIRAL DISSECTION. THE PT WENT TO SURGERY FOR REPAIR OF THE DISSECTION. PT STATUS IS LISTED AS "OKAY".

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention