BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 4 FR X 5 CM

    MDR report key: 20180204 · Received September 10, 2024

    Report

    Report Number
    3006425876-2024-00886
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    30801902124310
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER PROVIDED TWO PHOTOS FOR ANALYSIS. THE PHOTOS SHOW THE DISTAL END OF THE GUIDE WIRE KINKED. THE WIRE SNUBBER (K-04210-004) WAS NOT ATTACHED TO THE PROXIMAL END OF THE GUIDE WIRE TUBING BUT WAS WITHIN THE KIT. THE CUSTOMER ALSO RETURNED ONE, OPENED CVC KIT INCLUDING THE GUIDE WIRE WITHIN ITS ADVANCER AND A 21GA INTRODUCER NEEDLE FOR ANALYSIS. THE WIRE SNUBBER NOT RETURNED. NO OBVIOUS SIGNS OF WERE OBSERVED. VISUAL ANALYSIS OF THE GUIDE WIRE REVEALED ONE KINK ON THE DISTAL J-BEND. THE DISTAL J-BEND WAS MISSHAPEN BUT INTACT. MICROSCOPIC EXAMINATION CONFIRMED THE KINK IN THE GUIDE WIRE BODY. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. DURING FULL ASSEMBLY, THE PROXIMAL END OF THE GUIDE WIRE WOULD HAVE BEEN SECURED BY THE WIRE SNUBBER KEEPING THE ASSEMBLY INTACT DURING PACKAGING, SHIPPING , AND STORAGE, PROTECTING IT FROM DAMAGE. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED ON THE RETURNED GUIDE WIRE ASSEMBLY. THE KINK IN THE GUIDE WIRE WAS LOCATED 14 MM FROM THE DISTAL TIP. THE OVERALL LENGTH OF THE GUIDE WIRE MEASURED 455 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 449.2-458.8 MM PER GUIDE WIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED 0.434 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.432-0.457 MM PER GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE WAS FUNCTIONALLY TESTED PER THE PRODUCT INSTRUCTIONS-FOR-USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "IF USING STANDARD ARROW ADVANCER, RAISE THUMB AND PULL ARROW ADVANCER APPROXIMATELY 4 - 8 CM AWAY FROM ARROW RAULERSON SYRINGE OR INTRODUCER NEEDLE. LOWER THUMB ONTO ARROW ADVANCER AND WHILE MAINTAINING A FIRM GRIP ON GUIDEWIRE, PUSH ASSEMBLY INTO SYRINGE BARREL TO FURTHER ADVANCE GUIDEWIRE (REFER TO FIGURE 3A). CONTINUE UNTIL GUIDEWIRE REACHES DESIRED DEPTH." THE GUIDE WIRE WAS ADVANCED THROUGH THE RETURNED 21GA INTRODUCER NEEDLE TO FUNCTIONALLY TEST THE GUIDE WIRE. THE UNDAMAGED PORTIONS OF THE GUIDE WIRE PASSED THROUGH WITH LITTLE TO NO RESISTANCE. R & D WAS CONTACTED AS A PART OF THIS COMPLAINT INVESTIGATION. THAT STATED THAT THE GUIDE WIRE ASSEMBLY HAS A WIRE SNUBBER AT THE END OF THE ADVANCER TUBING THAT IS MEANT TO HOLD THE GUIDE WIRE IN PLACE. IT IS POSSIBLE THE GUIDE WIRE CAME OFF THE SNUBBER AND THEN GOT KINKED DURING SHIPPING AND TRANSPORT. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION , "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED , RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED." THE REPORT THAT THE GUIDE WIRE WAS KINKED WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. ONE KINK WAS OBSERVED ON THE DISTAL J-BEND OF THE GUIDE WIRE BODY. THE GUIDE WIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. DURING NORMAL ASSEMBLY, THE PROXIMAL END OF THE GUIDE WIRE WOULD HAVE BEEN SECURED BY THE WIRE SNUBBER KEEPING THE ASSEMBLY INTACT DURING PACKAGING, SHIPPING, AND STORAGE, PROTECTING IT FROM DAMAGE. HOWEVER, THE CUSTOMER PHOTOS SHOWS THE WIRE SNUBBER WAS SEPARATE FROM THE GUIDE WIRE ASSEMBLY. BASED ON THE CUSTOMER REPORT AND PHOTOS, STORAGE AND SHIPPING LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242099 ARROW CVC SET: 2-LUMEN 4 FR X 5 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F23D0726 30801902124310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.| NONE REPORTED.