BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIDA PTV CATHETER

    MDR report key: 4345684 · Received December 10, 2014

    Report

    Report Number
    2020394-2014-00551
    Event Type
    Death
    Date Received
    December 10, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 11, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    PMA / PMN Number
    K131002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. THE RELATIONSHIP OF THE DEVICE TO THE DEATH IS UNKNOWN. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. THIS FILE INDICATED ATTEMPTS WERE MADE TO THE FACILITY TO OBTAIN INFORMATION PERTAINING TO PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY). HOWEVER, AN EXPLANATION OF MISSING INFORMATION WAS NOT SUBMITTED TO THE FDA. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A SUCCESSFUL PT VALVULOPLASTY PROCEDURE A PERICARDIAL LEAK WAS DIAGNOSED. THE PATIENT WAS SENT TO THE OPERATING ROOM, BTU EXPIRED DURING TRANSIT. THE CAUSE OF DEATH AND RELATIONSHIP TO THE DEVICE IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797330 VIDA PTV CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death