BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULOC

    MDR report key: 16742843 · Received April 14, 2023

    Report

    Report Number
    1000408433-2023-00002
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    March 2, 2023
    Report Date
    May 3, 2023
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    MIJ
    UDI-DI
    04250195600844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MAMMOGRAM WAS PERFORMED ON THE PATIENT AND HE MAMMOGRAM DONE TODAY CONFIRMS THAT THE METAL PIECE WAS COMPLETELY REMOVED INTRAOPERATIVELY. A CONTROL MAMMOGRAM ALSO CONFIRMED THIS. AND NO ADDITIONAL INTERVENTION WAS NECESSARY.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INVESTIGATION REVEALED THAT A USER ERROR LED TO THE INCIDENT. THE ERROR PATTERN CAN BE GENERATED BY 2 POSSIBLE MISAPPLICATIONS. THE USER PUSHED THE WIRE TOO FAR OUT OF THE CANNULA (TOGETHER WITH THE GLUED METAL TUBE) OR THE USER PULLED THE CANNULA BACK TO REMOVE IT AFTER THE WIRE WAS RELEASED.  IN BOTH CASES, THE WIRE IS RELEASED AND THE GLUED METAL TUBE IS IN FRONT OF THE CANNULA TIP. THEN THE USER PULLED THE WIRE BACK INTO THE CANNULA AS MENTIONED IN THE COMPLAINT INFORMATION EMAIL. THIS CAUSED THE GLUED METAL TUBE TO WEDGE ON THE CANNULA TIP AND COME OFF. THE METAL TUBE IS GLUED TO THE WIRE, BUT NOT TOO MUCH FORCE IS NEEDED TO LOOSEN IT.  THE INSTRUCTIONS FOR USE STATES THAT THE WIRE SHOULD ONLY BE PUSHED INTO THE CANNULA UNTIL THE LAST VISIBLE MARKING ON THE WIRE HAS BEEN INSERTED INTO THE CANNULA HUB.  FURTHERMORE, IT IS STATED IN THE IFU THAT REPOSITIONING OF THE WIRE SHOULD ONLY BE DONE BEFORE PULLING OUT THE CANNULA. ONE OF THESE TWO INSTRUCTIONS IN THE IFU WAS NOT FOLLOWED BY THE USER WHEN USING THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, AFTER A BREAST BIOPSY THE PHYSICIAN ATTEMPTED TO IMPLANT A TULOC HARPOON, THE PHYSICIAN REPORTED THAT HE HAD TO READJUST THE HARPOON AND ON THE CONTROL MAMMOGRAM IT WAS OBSERVED A SMALL CYLINDER INSIDE THE BREAST THAT HAD DETACHED FROM THE HARPOON. THE PHYSICIAN VERIFIED THE PROPER FUNCTIONING OF THE HARPOON BEFORE USING IT. DURING TRACKING HE REMOVED THE HARPOON TO READJUST ITS POSITION WITHOUT ANY PARTICULAR TECHNICAL PROBLEM. HOWEVER ON THE FOLLOW UP MAMMOGRAM IT WAS FOUND THAT A 17MM LINEA METAL WAS STUCK INSIDE THE BREAST. IT WAS NOT THERE BEFORE REMOVAL. THE HARPOON WAS CHECKED AND A SMALL CYLINDRAL PIECE WAS MISSING FROM THE END OF THE WIRE. THE DEVICE WAS RETURNED FOR EXAMINATION AND IT WAS CONFIRMED THAT A SMALL PIECE WAS MISSING FROM THE END SECTION OF THE DEPLOYER. A FOLLOW UP WITH THE PHYSICIAN REVEALED THAT THE PATIENT WAS NOT AFFECTED BY THE PROCEDURE AND IN A SUBSEQUENT SURGERY ALREADY PLANED TO REMOVE THE PATHOLOGY THE METAL CYLINDER WAS REMOVED AS WELL. NO MORE TISSUE REQUIRED TO BE REMOVED FROM THE PATIENT AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. A FOLLOW UP MAMMOGRAM IS SCHEDULED FOR (B)(6) 2023. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129810 TULOC TULOC MIJ SOMATEX MEDICAL TECHNOLOGIES GMBH 271661 52193 04250195600844

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other