BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA PTV DILATATION CATHETER

    MDR report key: 11743384 · Received April 29, 2021

    Report

    Report Number
    2020394-2021-00933
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 2, 2021
    Report Date
    July 28, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    UDI-DI
    00801741090837
    PMA / PMN Number
    K131002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: ONE DEVICE WAS RETURNED FOR EVALUATION. HOWEVER, SINCE THE COMPLAINT SAMPLE WAS USED IN A HIV PATIENT IT WAS DEEMED AS INFECTIOUS AND NO SAMPLE EVALUATION COULD BE PERFORMED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR BALLOON RUPTURE AS NO FUNCTIONAL EVALUATION COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 08/2023),

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, IMAGES WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 08/2023).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. IT WAS FURTHER REPORTED THAT BALLOON ALLEGEDLY HAD TREMENDOUS AMOUNT OF WASTE IN IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646990 VIDA PTV DILATATION CATHETER VALVULOPLASTY CATHETERS OMZ BARD PERIPHERAL VASCULAR, INC. VDA100144 93VE0099 00801741090837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other