BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORODYN A

    MDR report key: 1071211 · Received July 3, 2008

    Report

    Report Number
    2243801-2008-00008
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 4, 2008
    Report Date
    July 2, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYG
    PMA / PMN Number
    K822806
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MFR TO BE EVALUATED. THE BALLOON APPEARED TO BE SLIGHTLY DISCOLORED ON VISUAL OBSERVATION. ON OBSERVATION UNDER THE MICROSCOPE, IT WAS FOUND THAT THERE WERE SEVERAL ALMOST PARALLEL LINES ON THE SURFACE OF THE BALLOON INDICATING THAT THE BALLOON MATERIAL WAS DEGRADED DUE TO SOME UNCONTROLLED EXTERNAL FACTOR. THE SURFACE DEGRADATION ON THE BALLOON DID NOT APPEAR TO BE ATTRIBUTED TO THE MANUFACTURING PROCESS OF THE PART. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON VIA STANDARD INFLATION SYRINGE. THE BALLOON COULD NOT BE INFLATED. ON PLACING BALLOON UNDER WATER AND TRYING TO INFLATE, IT WAS FOUND THAT THERE WAS A LEAK IN THE BALLOON SOMEWHERE NEAR THE MIDPOINT BETWEEN DISTAL AND PROXIMAL GLUE BANDS I.E. IN THE BALLOON MATERIAL ITSELF. NO OTHER PHYSICAL TESTING WAS POSSIBLE ON THE RETURNED SAMPLE. THE HOUSE RETAIN SAMPLES WERE TESTED PER SPEC AND FOUND TO PASS ALL VISUAL AND PHYSICAL TESTING. FURTHER TESTING WAS PERFORMED WITH INCREASED INFLATION VOLUME AND CYCLES AND NO FAILURES WERE NOTED. THERE ARE NO OTHER COMPLAINTS OF THIS NATURE REPORTED AGAINST THIS PART. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    RUPTURE OF ANGIOGRAPHY CATHETER; CUSTOMER INFLATED BALLOON BY CO2 GAS WITH FORMULARY QUANTITY, AND THEN THEY CARRIED IT TILL RIGHT VENTRICLE. AT THAT TIME THE BALLOON RUPTURED. SO THEY CHANGED THE CATHETER AND THE OPERATION WAS FINISHED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORODYN A ANGIOGRAPHIC BALLOON FLOATATION CATHETER DYG B. BRAUN MEDICAL, INC. AN505UP 60829858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other