BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYSHAK

    MDR report key: 780563 · Received November 10, 2006

    Report

    Report Number
    2523676-2006-00088
    Event Type
    Other
    Date Received
    November 10, 2006
    Date of Event
    August 29, 2006
    Report Date
    October 30, 2006
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    MAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MFR FOR EVAL. ONE USED CATHETER WAS RETURNED. THE BALLOON APPEARED INTACT AND VISUAL EXAMINATION DID NOT REVEAL A HOLE IN THE BALLOON. THESE BALLOON CATHETERS ARE MFG AND PURCHASED FROM NUMED, INC. THE SAMPLE AND ALL AVAILABLE INFO HAS BEEN FORWARDED TO NUMED FOR EVAL. IF NUMED'S EVAL REVEALS ANY ADD'L INFO, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: WHILE PERFORMING A VALVULOPLASTY PROCEDURE, THEY WERE APPLYING NEGATIVE PRESSURE TO THE BALLOON. THE PHYSICIAN NOTED A HOLE IN THE BALLOON, REMOVED THE BALLOON SYSTEM FROM THE BODY AND USED A NEW BALLOON. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE PT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK BALLOON DILATION CATHETER MAD B. BRAUN MEDICAL INC. PDC017 T2820

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other