BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACCESS PTA BALLOON DILATATION CATHETER

    MDR report key: 3457630 · Received September 30, 2013

    Report

    Report Number
    2020394-2013-00307
    Event Type
    Malfunction
    Date Received
    September 30, 2013
    Date of Event
    August 30, 2013
    Report Date
    September 4, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW WAS PERFORMED. THE LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER 93CW0165. THE DEVICE WAS RETURNED AND EVALUATED. THE INVESTIGATION IS UNCONFIRMED FOR DEFLATION ISSUES, AS THE BALLOON WAS ABLE TO BE DEFLATED WITHIN THE TIME SPECIFICATIONS. PER THE COMPLAINT COMMENTS, ONLY SALINE (I.E. NO CONTRAST) WAS USED TO INFLATE THE BALLOON. PER THE IFU, USE THE RECOMMENDED BALLOON INFLATION MEDIUM (50% CONTRAST MEDIUM/50% STERILE SALINE SOLUTION). ADDITIONALLY, PER THE COMPLAINT COMMENTS, ONLY ULTRASOUND WAS USED. PER THE IFU, WHEN THE CATHETER IS EXPOSED TO THE VASCULAR SYSTEM, IT SHOULD BE MANIPULATED WHILE UNDER HIGH-QUALITY FLUOROSCOPIC OBSERVATION. THEREFORE, IT IS UNKNOWN IF PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. PRECAUTIONS: USE THE RECOMMENDED BALLOON INFLATION MEDIUM (50% CONTRAST MEDIUM/50% STERILE SALINE SOLUTION). NEVER USE AIR OR OTHER GASEOUS MEDIUM TO INFLATE THE BALLOON. IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE/INTRODUCER SHEATH AS A SINGLE UNIT. USE OF THE VACCCESS PTA BALLOON DILATATION CATHETER. APPLY NEGATIVE PRESSURE TO FULLY EVACUATE FLUID FROM THE BALLOON. CONFIRM THAT THE BALLOON IS FULLY DEFLATED UNDER FLUOROSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INFLATION IN A BRACHIOCEPHALIC FISTULA, THE PTA BALLOON WOULD NOT DEFLATE. THE BALLOON AND THE INTRODUCER SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491748 VACCESS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93FX008

    Patients

    Seq Age Sex Outcome Treatment
    1