BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAVERSE 035

    MDR report key: 14629711 · Received June 8, 2022

    Report

    Report Number
    2020394-2022-00448
    Event Type
    Death
    Date Received
    June 8, 2022
    Date of Event
    May 19, 2022
    Report Date
    June 20, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    UDI-DI
    00801741092688
    PMA / PMN Number
    K142261
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION WAS RECEIVED AND THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS DEATH. H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H10: G3 H11: B5, E1, H1, H6 (PATIENT) H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE GUIDEWIRE STUCK AND UNABLE TO RETRIEVE BACK INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON SNAPPED OFF FROM THE BALLOON CATHETER SHAFT AND SEPARATED, LEAVING BALLOON PORTION INSIDE THE PATIENT'S RIGHT EXTERNAL ILLIAC. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA CATHETER BECAME STUCK ON THE GUIDEWIRE AND WAS UNABLE TO BE RETRIEVED BACK INTO THE SHEATH. UPON RETRACTION, THE BALLOON DETACHED FROM THE CATHETER SHAFT. IT WAS FURTHER REPORTED, IT WAS NOT VISUALLY CONFIRMED IF PTA BALLOON WAS REMOVED OR LEFT IN PATIENT. PATIENT EXPERIENCED ESCALATED HEART RATE, FOLLOWED BY USAGE OF DEFIBRILLATOR. PATIENT WAS TRANSFERRED TO HOSPITAL. IF WAS FURTHER REPORTED, THE PATIENT EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439280 ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. U3513056 UNKNOWN 00801741092688

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death