BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THRUWAY¿

    MDR report key: 20345285 · Received October 1, 2024

    Report

    Report Number
    2126666-2024-00066
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    August 21, 2024
    Report Date
    October 1, 2024
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K042338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED AT THE TIME OF THIS REPORT; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE (DFU), "FREE MOVEMENT OF THE GUIDEWIRE WITHIN THE CATHETER IS AN IMPORTANT FEATURE OF A STEERABLE GUIDEWIRE SYSTEM BECAUSE IT GIVES THE USER VALUABLE TACTILE INFORMATION. TEST THE SYSTEM FOR ANY RESISTANCE PRIOR TO USE." AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED, IT APPEARED THAT CLINICAL AND/OR PROCEDURAL FACTORS HAVE CONTRIBUTED TO THE EVENT AS REPORTED. ALTHOUGH IT WAS REPORTED THAT THE COMPLAINT WAS AGAINST THE CATHETER AND NOT THE THRUWAY GUIDEWIRE, THIS INCIDENT IS BEING FILED AS A GOOD FAITH EFFORT DUE TO THE REPORT THAT THE THRUWAY GUIDEWIRE WAS REMOVED WITH THE CATHETER. PATIENT INFORMATION WAS NOT AVAILABLE; THEREFORE, PART A COULD NOT BE COMPLETED. THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED; THEREFORE, SECTION D COULD NOT BE COMPLETED, INCLUDING THE UDI NUMBER. THE SECTIONS LEFT BLANK OR UNKNOWN ON THIS FORM COULD NOT BE COMPLETED DUE TO MISSING INFORMATION. AN ATTEMPT TO GATHER FURTHER DETAILS TO OBTAIN THE INFORMATION WAS MADE; HOWEVER, AT THE TIME OF THIS REPORT NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: THE CATHETER WAS NO LONGER WORKING AND BECAME BLOCKED. THE GUIDE WAS STUCK IN THE CATHETER, AND THE SURGEON HAD TO REMOVE THE WHOLE ASSEMBLY, WITHOUT ANY CONSEQUENCES FOR THE PATIENT. THE CATHETER BATCH NUMBER IS 34449031. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ALL STEPS WHAT IS THE NEXT COURSE OF ACTION?: N/A PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PATIENT OUTCOME: FULLY RECOVERED DEVICE ACQUIRED FROM A DISTRIBUTOR?: NO. (PER SALES REP'S EMAIL) THERE IS ONLY ONE COMPLAINT, FOR THE JETSTREAM CATHETER AND NOT FOR THE THRUWAY GUIDE. DEVICE 1: UPN 112266 002, MODEL NUMBER PV41340, LOT OR SERIAL NUMBER (B)(6) WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO QUESTION: WERE THERE ANY ERROR MESSAGES? IF YES, DESCRIBE THE MESSAGE: ANSWER: NO QUESTION: WAS SIGNIFICANT RESISTANCE NOTED BEFORE THE DEVICE STOPPED SPINNING? ANSWER: NO QUESTION: DID THE PHYSICIAN ATTEMPT TO RESTART ROTATION AFTER IT STOPPED? ANSWER: YES QUESTION: WHAT MODE WAS THE DEVICE IN WHEN THE BLADES STOPPED SPINNING (BLADES UP, BLADES DOWN, REX)? ANSWER: BLADES DOWN. QUESTION: DID THE USER ATTEMPT TO ACTIVATE ROTATION AFTER THE FAILURE IN OTHER MODES? IF YES, WHAT MODES WERE ATTEMPTED (BLADES UP, BLADES DOWN, REX)? ANSWER: YES, WITH THE REX. QUESTION: SIZE/TYPE/BRAND OF THE GUIDEWIRE USED? ANSWER: THRUWAY 0,014 300M. QUESTION: WERE THERE ANY VISIBLE DEFECTS NOTED WHEN THIS ISSUE OCCURRED (LEAK, KINK, ETC.)? ANSWER: NO QUESTION: WAS ATHERECTOMY LUBRICANT USED? IF YES, PLEASE PROVIDE TYPE/BRAND: ANSWER: NO QUESTION: SIZE/TYPE/BRAND OF THE GUIDEWIRE USED? ANSWER: THRUWAY 0,014 300M QUESTION: CAN YOU PLEASE FURTHER CLARIFY WHAT IS MEANT BY 'STOPPED WORKING'? ANSWER: THE CATHETER HAS STOPPED ROTATING QUESTION: DID AN ERROR MESSAGE DISPLAY WHEN THIS ISSUE OCCURRED? IF YES, WHAT DID THE MESSAGE STATE? ANSWER: NO. QUESTION: HOW WAS THE DEVICE REMOVED FROM THE PATIENT? ANSWER: WITH THE GUIDEWIRE QUESTION: IF THERE WAS A VISIBLE DEFECT, FROM WHAT PORTION OF THE DEVICE DID IT OCCUR (EX: PUMP, SHAFT, TUBING, LUER, ETC.)? ANSWER: NO QUESTION: WERE THERE ANY VISIBLE DEFECTS NOTED WHEN THIS ISSUE OCCURRED (LEAK, BREAK, KINK ETC.)? ANSWER: NO QUESTION: WHAT SIZE AND BRAND GUIDEWIRE WAS USED? ANSWER: THRUWAY 0,014 300M QUESTION: WAS ATHERECTOMY LUBRICANT USED? IF YES, PLEASE PROVIDE TYPE/BRAND: ANSWER: NO QUESTION: WHEN DID THIS ISSUE OCCUR (EX AFTER 30 SEC, DURING SECOND PASS, PRIOR TO INSERTION INTO LESION ETC)? ANSWER: AFTER 5 MINUTES QUESTION: WAS THE DEVICE REMOVED FROM THE PATIENT IN ONE PIECE? ANSWER: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369438 THRUWAY¿ WIRE, GUIDE, CATHETER DQX LAKE REGION MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown