BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMC/3 ARTERIAL NEEDLE 21GA X 1

    MDR report key: 17305462 · Received July 12, 2023

    Report

    Report Number
    0001625425-2023-01113
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 26, 2023
    Report Date
    August 30, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    GDF
    UDI-DI
    00886333208371
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE BATCH RECORDS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION AND NO DEVIATIONS OR ANOMALIES WERE FOUND. PER ARGON IFU9012, "THE GUIDEWIRE SHOULD NOT BE WITHDRAWN THROUGH THE NEEDLE. DAMAGE OR SHEARING OF GUIDEWIRE MAY OCCUR." AFTER THREE NOTIFICATIONS, THE SAMPLE FROM THE ALLEGED COMPLAINT HAS NOT RETURNED. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT A DEVICE TO EVALUATE, DETERMINING ROOT CAUSE OR CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, THIS COMPLAINT MAY BE REOPENED FOR FURTHER EVALUATION AT THAT TIME.

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Description of Event or Problem · 0

    TIP OF NITREX GUIDEWIRE SHEARED OFF AND WAS RETAINED EXTRAVASCULARLY WHILE ATTEMPTING LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDS CARDIAC CATH. IMMEDIATELY CONTACTED SURGEON, AND THEN PEDS SURGERY DOCTOR. DETERMINED IT WAS SAFE TO LEAVE IN PLACE. PROCEEDED AND COMPLETED CASE WITH NO OTHER ISSUES. DOCTOR NOTIFIED PATIENT FAMILY AT COMPLETION OF CASE. SPECIFIC ITEM: EV3 NITREX .018" X 80 CM GUIDEWIRE. REF#: (B)(4), LOT#: 6675783. USED IN CONJUNCTION WITH ARGON MEDICAL DEVICES AMC/3 ARTERIAL NEEDLE 21GA X 1" REF#: (B)(4). WHAT WAS THE ORIGINAL INTENDED PROCEDURE? LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDS CARDIAC CATH.

    Description of Event or Problem · 0

    TIP OF NITREX GUIDEWIRE SHEARED OFF AND WAS RETAINED EXTRAVASCULARLY WHILE ATTEMPTING LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDS CARDIAC CATH. IMMEDIATELY CONTACTED SURGEON, AND THEN PEDS SURGERY DOCTOR. DETERMINED IT WAS SAFE TO LEAVE IN PLACE. PROCEEDED AND COMPLETED CASE WITH NO OTHER ISSUES. DOCTOR NOTIFIED PATIENT FAMILY AT COMPLETION OF CASE. SPECIFIC ITEM: EV3 NITREX .018" X 80 CM GUIDEWIRE. REF# N180801, LOT# 6675783. USED IN CONJUNCTION WITH ARGON MEDICAL DEVICES AMC/3 ARTERIAL NEEDLE 21GA X 1" REF# 195311. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : LEFT FEMORAL ARTERIAL ACCESS FOR DIAGNOSTIC PEDS CARDIAC CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239594 AMC/3 ARTERIAL NEEDLE 21GA X 1 ARTERIAL NEEDLE GDF ARGON MEDICAL DEVICES 195311 11374158 00886333208371

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R