MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN918647
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: incident occurred on (b)(6) 2023.In the operating theatre during a puncture in the left jugular vein under ultrasound, it was found that the puncture needle could not be inserted through the guide.The guide was stuck in the needle, and the procedure was therefore unsuccessful.A compression and the presence of a visible hematoma on ultrasound made it impossible to puncture again on the left with a 2nd kit.So a new puncture on the right was carried out with a kit from another reference.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4) the report that the guide wire unravelled was confirmed through examination of the returned sample.The customer returned one guide wire assembly and a 18ga introducer needle for analysis.Signs-of-use in the form of biological material were observed.Visual analysis of the guide wire revealed that it was unravelled towards the distal end.The unravelled portion was lodged inside the introducer needle.Moderate force was required to free the guide wire.Once freed, large quantities of dried biological material were observed on the coils of the guide wire.Further microscopic examination confirmed the damage.The core wire appeared to separate directly adjacent to the distal weld.The distal and proximal welds appeared full and spherical.The broken core wire measured 602mm in length via calibrated ruler, which was within the specification of 596mm-604mm per the guide wire product drawing.The outside diameter (od) of the guide wire measured 0.800mm via calibrated caliper, which was within the od specification of 0.788mm-0.826mm per the guide wire product drawing.The needle cannula outer diameter measured 0.0495" via calibrated caliper, which was within the specificat ion limits of 0.0495"-0.0505" per the cannula product drawing.The cannula inner diameter measured 0.041" via calibrated pin gauge, which was within the specification limits of 0.041"-0.043" per the cannula product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".Moderate force was required to remove the guide wire from the cannula.Large quantities of dried biological material were observed exiting the cannula.Once removed, the proximal end of the guide wire was inserted through the needle cannula.Resistance was encountered as more biological material exited the needle cannula.Once all biological material was removed, the guide wire passed through the cannula with little to no issue.A manual tug test confirmed that the proximal weld was intact.The ifu provided with the kit informs the user, "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".A device history record review was performed, and no relevant manufacturing issues were identified.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: incident occurred on (b)(6)2023.In the operating theatre during a puncture in the left jugular vein under ultrasound, it was found that the puncture needle could not be inserted through the guide.The guide was stuck in the needle, and the procedure was therefore unsuccessful.A compression and the presence of a visible hematoma on ultrasound made it impossible to puncture again on the left with a 2nd kit.So a new puncture on the right was carried out with a kit from another reference.

• Brand Name: CVC SET: 3-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18464100
• Report Number: 3006425876-2024-00037
• Device Sequence Number: 7117026
• Product Code: DQY
• UDI-Device Identifier: 10801902029017
• UDI-Public: 10801902029017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: IPN918647
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F22E7679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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 Age: 52 YR
• Patient Sex: Unknown