BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM

    MDR report key: 22328321 · Received June 25, 2025

    Report

    Report Number
    9680794-2025-00523
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 31, 2025
    Report Date
    June 2, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQX
    UDI-DI
    50801902117644
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Additional Manufacturer Narrative · 0

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE COMPLAINT OF AN UNRAVELED GUIDEWIRE COULD NOT BE CONFIRMED BY THE PHOTO AS THE IMAGE PROVIDED WAS ONLY AN ILLUSTRATION OF WHERE THE CATHETER WAS BLOCKED, AND IT DID NOT REVEAL ANY DEFECT ON THE ACTUAL SAMPLE. A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT INSTRUCTS THE USER, "INSERT TIP OF GUIDEWIRE THROUGH INTRODUCER NEEDLE INTO ARTERY (UNTIL DEPTH-MARKING [IF PROVIDED] ON WIRE ENTERS HUB OF NEEDLE). AT THIS POINT, THE DEPTH-MARKING ENTERING HUB SHOWS THAT TIP OF WIRE LEAVES TIP OF INTRODUCER NEEDLE AND ENTERS VESSEL. IF CATHETER/NEEDLE ASSEMBLY IS USED, REMOVE NEEDLE AND INSERT GUIDEWIRE THROUGH CATHETER INTO ARTERY AS DESCRIBED ABOVE. IF "J" TIP GUIDEWIRE IS USED, PREPARE FOR INSERTION BY SLIDING STRAIGHTENING TUBE OVER "J" TO STRAIGHTEN AND ADVANCE GUIDEWIRE TO REQUIRED DEPTH. PRECAUTION: DO NOT ADVANCE GUIDEWIRE UNLESS THERE IS FREE BLOOD FLASHBACK." WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "ONCE WE HAVE ACCESS TO THE VESSEL, WE THREAD THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE. THEN, WE REMOVE THE INTRODUCER NEEDLE AND RUN THE CATHETER OVER THE GUIDEWIRE WITHIN THE FEMORAL ARTERY. UNFORTUNATELY, WE HAVE NOT BEEN ABLE TO ADVANCE THE FEMORAL ARTERIAL CATHETER OVER THE GUIDEWIRE PAST 0.5-1CM. SOME FEMORAL ARTERIAL CATHETERS NARROW SIGNIFICANTLY OR KINK AT AROUND 0.5 - 1CM, SO THAT WE CANNOT ADVANCE THE CATHETER OVER THE GUIDEWIRE INTO THE FEMORAL ARTERY." ADDITIONAL INFORMATION RECEIVED STATES "ALL COMPONENTS REMOVED FROM PATIENT WITH WIRE VISIBLY FRAYED BUT NOT WITHIN PATIENT." IT WAS REPORTED THERE WAS NO OVERT HARM TO THE PATIENT, POTENTIAL BLOOD LOSS FROM WIRE FAILURE AND PRESSURE APPLIED GROIN". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED" DUE TO UNRELATED ISSUES. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00525, 9680794-2025-00524, AND 9680794-2025-00521.

    Description of Event or Problem · 0

    IT WAS REPORTED "ONCE WE HAVE ACCESS TO THE VESSEL, WE THREAD THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE. THEN, WE REMOVE THE INTRODUCER NEEDLE AND RUN THE CATHETER OVER THE GUIDEWIRE WITHIN THE FEMORAL ARTERY. UNFORTUNATELY, WE HAVE NOT BEEN ABLE TO ADVANCE THE FEMORAL ARTERIAL CATHETER OVER THE GUIDEWIRE PAST 0.5-1CM. SOME FEMORAL ARTERIAL CATHETERS NARROW SIGNIFICANTLY OR KINK AT AROUND 0.5 TO 1CM, SO THAT WE CANNOT ADVANCE THE CATHETER OVER THE GUIDEWIRE INTO THE FEMORAL ARTERY." ADDITIONAL INFORMATION RECEIVED STATES "ALL COMPONENTS REMOVED FROM PATIENT WITH WIRE VISIBLY FRAYED BUT NOT WITHIN PATIENT." IT WAS REPORTED THERE WAS NO OVERT HARM TO THE PATIENT, POTENTIAL BLOOD LOSS FROM WIRE FAILURE AND PRESSURE APPLIED GROIN". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED" DUE TO UNRELATED ISSUES. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00525, 9680794-2025-00524, 9680794-2025-00523, AND 9680794-2025-00521.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368730 ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM WIRE, GUIDE, CATHETER DQX ARROW INTERNATIONAL LLC 33F25C0742 50801902117644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED