BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PTA BALLOON DILATATION CATHETER

    MDR report key: 1945244 · Received December 10, 2010

    Report

    Report Number
    2020394-2010-00355
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K052236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER BEING USED IN THE JUGULAR VEIN THE PTA BALLOON DILATATION CATHETER WAS DIFFICULT TO REMOVE THROUGH THE SHEATH AND THE BALLOON APPEARED TO SEPARATE FROM THE CATHETER AS IT WAS ENTERING THE LUMEN OF THE SHEATH. THE BALLOON HAD BEEN INFLATED ONCE AT 5 ATM. REPORTEDLY, THE PT WAS BEING TREATED WITH ANGIOPLASTY FOR "WEBBING-LIKE TISSUE" IN THE JUGULAR VEIN THAT IS COMMON IN MULTIPLE SCLEROSIS PTS. THE BALLOON CATHETER WAS ULTIMATELY REMOVED THROUGH THE SHEATH IN ITS ENTIRETY AND ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFUJ3151

    Patients

    Seq Age Sex Outcome Treatment
    1