BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURA BLN 20G X 7.5CM, WIRE 19.4CM

    MDR report key: 18122536 · Received November 13, 2023

    Report

    Report Number
    0001625425-2023-01235
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    August 16, 2023
    Report Date
    September 1, 2024
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    GAA
    UDI-DI
    00886333007493
    PMA / PMN Number
    K974741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ONE OPENED NEEDLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THE NEEDLE TO BE BENT FROM USE, WITH THE HARPOON PRESENT. THE CANNULA WAS NOT RETURNED FOR INVESTIGATION. IT IS POSSIBLE THAT THE NEEDLE HAD MOVED WITHIN THE CANNULA BEFORE INSERTION INTO THE PATIENT, WHICH COULD CAUSE THE MARKER TO NOT DEPLOY CORRECTLY. WITHOUT ANY IMAGES, THIS COULD NOT BE CONFIRMED. SINCE THE COMPLAINT COULD NOT BE CONFIRMED, NO CORRECTIVE ACTION WAS TAKEN.

    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.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Description of Event or Problem · 0

    FOLLOWING THE PLACEMENT OF A SIMPLE HARPOON UNDER ULTRASOUND CONTROL AT THE LEVEL OF THE QSE LESION, THE LATTER MIGRATED INSIDE THE BREAST OF MRS. (B)(6). THE MAMMOGRAPHY IMAGE THEN TAKEN SHOWED US THAT THE HARPOON HAD MIGRATED WITH A PROXIMAL END AT THE LEVEL OF THE QSE AND A DISTAL END IN THE PRE-PECTORAL AREA. A SECOND DOUBLE J HARPOON WAS THEN PLACED. GOOD POSITIONING ON THE CONTROL SHOTS. THE GYNECOLOGIST MANAGED TO REMOVE THE DEFECTIVE HARPOON FROM THE PATIENT'S BREAST. IT TURNS OUT THAT IT IS DEFECTIVE: NO HOOK OR THE HOOK HAS NOT DEPLOYED.

    Description of Event or Problem · 0

    FOLLOWING THE PLACEMENT OF A SIMPLE HARPOON UNDER ULTRASOUND CONTROL AT THE LEVEL OF THE QSE LESION, THE LATTER MIGRATED INSIDE THE BREAST OF MRS. A-DS. THE MAMMOGRAPHY IMAGE THEN TAKEN SHOWED US THAT THE HARPOON HAD MIGRATED WITH A PROXIMAL END AT THE LEVEL OF THE QSE AND A DISTAL END IN THE PRE-PECTORAL AREA. A SECOND DOUBLE J HARPOON WAS THEN PLACED. GOOD POSITIONING ON THE CONTROL SHOTS. THE GYNECOLOGIST MANAGED TO REMOVE THE DEFECTIVE HARPOON FROM THE PATIENT'S BREAST. IT TURNS OUT THAT IT IS DEFECTIVE: NO HOOK OR THE HOOK HAS NOT DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228905 ACCURA BLN 20G X 7.5CM, WIRE 19.4CM BLN GAA ARGON MEDICAL DEVICES BLN20075 11456180 00886333007493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention