BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACCESS PTA BALLOON DILATION CATHETER

    MDR report key: 3850789 · Received March 20, 2014

    Report

    Report Number
    2020394-2014-00098
    Event Type
    Injury
    Date Received
    March 20, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 20, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA. THIS IS THE FIRST COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND FAILURE MODE. THE DEVICE WAS RETURNED WITH PROLAPSED BALLOON MATERIAL OVER THE DISTAL TIP. THE TIP OF THE SHEATH WAS FLARED. THE DISTAL TIP OF THE INTRODUCER SHEATH WAS SLIGHTLY FLARED, WHICH TYPICALLY INDICATES RETRACTION ISSUES; THEREFORE, THE INVESTIGATION IS CONFIRMED FOR RETRACTION DIFFICULTY. THE INVESTIGATION IS INCONCLUSIVE FOR A BALLOON RUPTURE DUE TO POOR SAMPLE CONDITION. PER THE REPORTED EVENTS, THE BALLOON WAS INFLATED NEAR A STENT. IT IS UNKNOWN IF THE STENT CONTRIBUTED TO THE REPORTED FAILURE. AS THE BALLOON ALLEGEDLY RUPTURED FIRST, THE RUPTURE LIKELY CONTRIBUTED TO THE REPORTED RETRACTION ISSUES WHERE THE BALLOON SHEARED IN HALF. IT WAS ALSO REPORTED THAT A HAND SYRINGE WAS USED TO INFLATE THE DEVICE. PER THE IFU, A LUER-LOCK SYRINGE WITH A MANOMETER SHOULD BE USED FOR INFLATION. IT IS UNKNOWN IF THE RUPTURE WAS CAUSED BY OVERPRESSURIZING THE BALLOON. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED AFTER AN INFLATION (ATM UNKNOWN) THAT WAS PERFORMED IN A DIALYSIS FISTULA, PROXIMAL TO A PREVIOUSLY IMPLANTED STENT. DURING RETRACTION, THE BALLOON TORE IN HALF AND THEN COULD NOT BE WITHDRAWN INTO THE SHEATH. THE ACCESS SITE WAS SLIGHTLY ENLARGED, AND THE CATHETER AND THE INTRODUCER SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT. THERE WAS NOT REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166831 VACCESS PTA BALLOON DILATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93LX0164

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention