MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, patient needs to establish central venous access for lung nodule surgery, using central venous catheter kit, after successful puncture via internal jugular vein, the swg could not be withdrawn from ars, resulting in re-puncturing and increasing patient's suffering." the operator changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "on (b)(6) 2024, patient needs to establish central venous access for lung nodule surgery, using central venous catheter kit, after successful puncture via internal jugular vein, the swg could not be withdrawn from ars, resulting in re-puncturing and increasing patient's suffering." the operator changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly for analysis.The guide wire cap was not returned.Signs of use were observed on the guide wire.Visual analysis revealed the guide wire contained one major kink.The distal j-bend was slightly 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.Visual analysis of the ars could not be performed as it was not returned for analysis.The kink in the guide wire was located 524 mm from the proximal tip.The overall length of the guide wire measured 600 mm, which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.789 mm, which is within the specification limits of 0.788-0.826 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, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The undamaged portions of the guide wire passed through both components with little to no resistance.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 kinked during use was confirmed through examination of the returned sample.The guide wire contained multiple kinks.Despite this, the guide wire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use , unintentional use error likely contributed to this event.However, the probable cause of guide wire and ars resistance could not be determined based upon the information provided and without the ars returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 5 FR X 20 CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20771072
• Report Number: 3006425876-2024-01176
• Device Sequence Number: 12784433
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)230215(17)280131(10)71F23B0900(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F23B0900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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