BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA PTV CATHETER

    MDR report key: 5629449 · Received May 3, 2016

    Report

    Report Number
    2020394-2016-00420
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    March 24, 2016
    Report Date
    April 7, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    PMA / PMN Number
    K131002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A COMPLETE MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER IS UNKNOWN. VISUAL INSPECTION: AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION, A VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION, A FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: THE CURRENT VIDA PTV CATHETER INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TREATING A VENOUS ANASTOMOSIS THE PTA BALLOON ALLEGEDLY RUPTURED AT 12 ATM ON THE FIRST INFLATION. REPORTEDLY, THERE WAS NO RETRACTION ISSUES. THERE WAS NO ADDITIONAL TREATMENT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282020 VIDA PTV CATHETER PTA DILATATION BALLOON CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1