BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS

    MDR report key: 11900308 · Received May 28, 2021

    Report

    Report Number
    3005334138-2021-00327
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 28, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DWZ
    PMA / PMN Number
    K991486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, G6, H2, H3, H6 THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AS SUPPORTED BY THE RECEIVING INSPECTION RESULTS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 3005334138-2021-00328. DURING THE BIOPSY OF RV MYOCARDIAL TISSUE, THE JAWS ON THE FORCEPS WOULD NOT CLOSE. THE DEVICE WAS REPLACED, BUT THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. THE CASE WAS UNABLE TO BE COMPLETED DUE TO THIS ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801602 PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS DEVICE, BIOPSY, ENDOMYOCARDIAL DWZ ST. JUDE MEDICAL 408296 9941140

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PROCURE FORCEPS