BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 799432 · Received December 27, 2006

    Report

    Report Number
    2523676-2006-00112
    Event Type
    Death
    Date Received
    December 27, 2006
    Date of Event
    December 8, 2006
    Report Date
    December 22, 2006
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DXF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THESE BALLOON CATHETERS ARE MANUFACTURED AND PURCHASED FROM NUMED, INC. IT WAS REPORTED THE ACTUAL DEVICE WAS DESTROYED BY THE USER FACILITY AND IS NOT AVAILABLE FOR THE MANUFACTURER TO EVALUATE. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO NUMED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NEITHER THE MANUFACTURER (NUMED) NOR THE DISTRIBUTOR (B. BRAUN MEDICAL) UNDERSTAND THE TERM "MV APPARATUS" AS REPORTED BY THE USER FACILITY. FOLLOW-UP CALLS TO THE FACILITY TO ASK FOR AN EXPLANATION HAVE NOT BEEN RETURNED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: "TOOK A NEWBORN TO THE LAB TO PERFORM A SEPTOSTOMY. DR. PERFORMED IT TWICE, WHICH WENT WELL. HOWEVER, WHEN ANOTHER DR. PULLED, THE BALLOON RUPTURED AND AVULSED OFF THE CATHETER. THE FRAGMENTS BECAME LOST IN THE BABY'S HEART. AFTER MANY ATTEMPTS TO RETRIEVE, SHE WAS TAKEN TO THE OR TO RETRIEVE; HOWEVER, WAS UNSUCCESSFUL. SHE WAS TAKEN BACK TO THE OR 2 DAYS LATER BY THE CARDIAC SURGEON AND SUBSEQUENTLY DIED. THE BALLOON APPEARED TO BE IN THE MV APPARATUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ATRIOSEPTOSTOMY BALLOON CATHETER DXF B. BRAUN MEDICAL, INC. SPT003 AC0280

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Congenital Anomaly| D