MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN919476
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the wire is angled in the catheter.The user has injured themselves during this procedure." additional information received reports the guidewire kinked and unraveled during removal from the catheter."the doctor probably had no significant injury only the glove was damaged".No medical intervention was reported for the user.There was no patient harm.A new catheter was used.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided two images showing the kit lidstock and a guide wire inserted through an 18ga introducer needle.Visual analysis revealed that the guide wire was damaged.The customer returned one, opened kit for analysis.The guide wire assembly and the 18ga introducer needle will be analyzed as part of this complaint investigation.It was observed that the guide wire was returned inserted through the needle.Signs of use were observed inside the needle hub.Visual analysis revealed that the guide wire was stuck inside the needle cannula and was unraveled from the distal end.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The distal weld was present at the end of the coil wire.Both welds appeared full and spherical.Visual inspection of the needle did not reveal any defects or anomalies.The broken core wire measured 684mm, which is within the specification of 678mm-688mm per the guide wire product drawing.The outer diameter measured 0.856mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The outer diameter of the cannula measured 0.04995", which is within the specification limits of 0.04950"-0.0505" per the cannula product drawing.The cannula inner diameter measured 0.041", which is within the specification limits of 0.041"-0.043" per the cannula product drawing.The guide wire was removed from the cannula with little to no difficulty.Once removed, the needle was attached to a lab inventory arrow raulerson syringe (ars).The proximal end of the guide wire was able to pass through the subassembly with little to no issue.Performed per ifu statement , "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply undue force on guidewire to reduce risk of possible breakage".The ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and introducer needle met all dimensional and functional requirements.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the wire is angled in the catheter.The user has injured themselves during this procedure." additional information received reports the guidewire kinked and unraveled during removal from the catheter."the doctor probably had no significant injury only the glove was damaged".No medical intervention was reported for the user.There was no patient harm.A new catheter was used.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17247418
• Report Number: 3006425876-2023-00604
• Device Sequence Number: 6831367
• Product Code: FOZ
• UDI-Device Identifier: 00801902102164
• UDI-Public: 00801902102164
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN919476
• Device Catalogue Number: CS-15123-F
• Device Lot Number: 71F22F1520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown