BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAK-NV¿. MICROPUNCTURE KIT

    MDR report key: 18007975 · Received October 25, 2023

    Report

    Report Number
    3011642792-2023-00070
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    October 18, 2023
    Report Date
    October 18, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    GCB
    UDI-DI
    00884450088821
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING ACCESS FOR NEPHROSTOMY CATHETER PLACEMENT, A PUNCTURE OF THE RENAL PELVIS WAS PERFORMED WITH A MICROPUNCTURE SET. THE ACCESS PROCEDURE WAS COMPLICATED FOR THE CLINICIAN. THE MICRO-MANDREL ACCESS WIRE WAS PASSED THROUGH THE MICRONEEDLE DOWN INTO THE URETHRA. THE NEEDLE WAS THEN REMOVED, AND THE ACCOMPANYING CATHETER WAS PASSED OVER THE MANDREL/MICROWIRE. IT WAS THEN OBSERVED THAT THE SOFT PART OF THE ACCESS MICRO-WIRE TIP (DISTAL END) HAD DETACHED WITHIN THE PATIENT'S URETHRA. NOT MUCH MANIPULATION OF THE WIRE [MANDIBLE] WAS PERFORMED. THE DETACHED TIP WAS REMOVED WITH A SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566995 MAK-NV¿. MICROPUNCTURE KIT NEEDLE, CATHETER GCB MERIT MEDICAL SYSTEMS MEXICO 00884450088821

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ACCESS NEEDLE| ACCESS SHEATH