BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA BALLOON VALVULOPLASTY CATHETER

    MDR report key: 12612003 · Received October 12, 2021

    Report

    Report Number
    2020394-2021-01860
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 9, 2021
    Report Date
    November 23, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    UDI-DI
    00801741090912
    PMA / PMN Number
    K131002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT INVESTIGATION SUMMARY: ONE VIDA PTV DILATATION CATHETER HAS BEEN RECEIVED FOR THE EVALUATION. ON THE VISUAL EVALUATION, THE DEVICE WAS NOTED BLOODY AND NO OTHER SPECIFIC ANOMALIES WERE NOTED. ON THE FUNCTIONAL EVALUATION, AN IN-HOUSE PRESTO INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO 6 ATM. BALLOON INFLATED AND MAINTAINED PRESSURE AND THE BALLOON WAS THEN DEFLATED WITHOUT ISSUE. NO OTHER FUNCTIONAL TESTING WAS PERFORMED. THEREFORE THE INVESTIGATION FOR THE REPORTED INFLATION ISSUE WAS UNCONFIRMED, AS THE BALLOON WAS SUCCESSFULLY INFLATED WITHOUT ANY ISSUE UPON INFLATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED INFLATION ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. 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: 07/2022), G3. H11: E1, G2, H6 (METHOD, RESULT, CONCLUSION). 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 : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT HOLD PRESSURE. 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 RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 07/2022).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY WOULD NOT HOLD PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516796 VIDA BALLOON VALVULOPLASTY CATHETER BALLOON VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. VDA100202 93UD0063 00801741090912

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown