BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIORITYONE

    MDR report key: 19786017 · Received July 19, 2024

    Report

    Report Number
    3009500972-2024-00005
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 19, 2024
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    QEZ
    UDI-DI
    04543334177254
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, WE PERFORMED OUT THE FOLLOWING INVESTIGATION. USING THE ELIMINATE DEVICE (FAMILY OF PRIORITY ONE AC) AND A PTCA TRAINER, WE ATTEMPTED TO REPRODUCE THE DISTAL MARKER SEPARATION OBSERVED IN THE INVOLVED DEVICE. WE SET A GUIDEWIRE OF THE APPROPRIATE SIZE ON THE ELIMINATE SAMPLE AND INSERTED A GUIDING CATHETER OF THE APPROPRIATE SIZE INTO THE PTCA TRAINER. WE THEN PERFORMED GUIDEWIRE OPERATIONS AND FORMED A LOOP ON THE COMBINATION GUIDEWIRE. IN THIS STATE, WE OPERATED THE ELIMINATE SAMPLE. WHEN A LOOP WAS FORMED ON THE GUIDEWIRE, IT CONTINUED TO BE PULLED AGAINST RESISTANCE. THE GUIDEWIRE LUMEN BEGAN TO TEAR FROM THE PROXIMAL PORT AND CONTINUED TO TEAR ALONG ITS ENTIRE LENGTH, RESULTING IN THE DISTAL RADIOPAQUE MARKER OF THE ELIMINATE DEVICE BEING TORN OFF. RESULT: THE SIMULATION TEST SHOWED THE SAME REPRODUCIBILITY OF DAMAGE AS OBSERVED IN THE DEVICE INVOLVED. IN OUR COMPANY, WE CONDUCT VISUAL INSPECTIONS ON ALL PRIORITY ONE AC DEVICES. AFTER REVIEWING THE DEVICE HISTORY RECORDS FOR LOT 230700660, WE FOUND NO ABNORMALITIES THAT COULD CAUSE THE SEPARATION OF THE DISTAL MARKER. WE INVESTIGATED THE COMPLAINT RECORDS FOR PRODUCTION LOT 230700660 OF THE DEVICE IN QUESTION AND FOUND NO SIMILAR COMPLAINTS REPORTED IN THE PAST. BASED ON PAST EXPERIENCES, IT IS KNOWN THAT OUR PRIORITY ONE AC MAY CAUSE THE GW LUMEN TO TEAR AND THE TIP MARKER TO COME OFF WHEN THE REMOVAL OPERATION IS PERFORMED WHILE THE COMBINATION GW IS STUCK. IT WAS CONSIDERED THAT THE SEPARATION OF DISTAL PART THAT OCCURRED IN THE INVOLVED DEVICE MAY HAVE OCCURRED BY THE SAME MECHANISM: 1) THE ASPIRATION CATHETER IS BEING PULLED, LEAVING THE GUIDE-CATHETER AND GUIDEWIRE IN PLACE. 2) A LOOP IS BEING FORMED ON GUIDEWIRE, AND OPERATOR MAY FEEL RESISTANCE AGAINST WITHDRAWAL. 3) THE LOOPED GUIDEWIRE MAKES GW-LUMEN TUBE BECOME TORN, AND ASPIRATION CATHETER AND GUIDEWIRE ARE STUCK IN GUIDE-CATHETER. HOWEVER, SINCE THE DEVICE INVOLVED WAS NOT RETURNED AND THE DAMAGE STATUS COULD NOT BE CONFIRMED, THE CAUSE OF THE SEPARATION OF THE DISTAL PART IN THE DEVICE COULD NOT BE IDENTIFIED IN THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE OR DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3B: GENDER: N/A. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. TERUMO MEDICAL PRODUCTS (TMP)(IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO CLINICAL SUPPLY CO., LTD. (MANUFACTURER) REGISTRATION NO. 3009500972.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE ASPIRATION CATHETER, PRIORITY ONE, WAS USED FOR A THROMBECTOMY. MULTIPLE ATTEMPTS WERE SUCCESSFUL (5-6 TIMES). THERE WAS MORE CLOT DISTALLY, SO THEY ADVANCED THE CATHETER BUT STUCK. WHEN PULLING IT, THE CATHETER'S TIP DISLODGED IN THE LEFT MAIN. AN ATTEMPT TO EXTRACT THE FRAGMENT WAS MADE WITHOUT SUCCESS, THEN IT MIGRATED TO THE THORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917915 PRIORITYONE ASPIRATION CATHETER QEZ TERUMO CLINICAL SUPPLY CO., LTD. UG1602 230700660 04543334177254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other