MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN030777
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spring wire j-tip "has dent and almost fracture".The spring wire guide was stuck in the arrow raulerson syringe (ars) and could not be removed.The user removed the ars along with the spring wire guide.A new kit was used to complete the procedure.No patient harm was reported.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The customer provided one photo for evaluation, which showed a kinked guide wire within its advancer assembly.The customer returned one guide wire and the product lidstock for evaluation.The guide wire was returned within the advancer tubing and showed evidence of use.The arrow raulerson syringe (ars) was not returned.Visual inspection of the guide wire revealed a kink towards the distal end of the body.Offset coils were also observed towards the distal tip.The distal j-bend was misshapen but intact.Microscopic examination confirmed the damage.Both welds were observed to be present and appeared full and spherical.Visual inspection of the ars could not be performed as it was not returned.The kinks in the guide wire were located 3mm and 19mm from the distal tip and the guide wire total length measured 600mm via calibrated ruler, which was within the specifications of 596-604mm per product drawing.The guide wire outer diameter (od) measured 0.813mm via calibrated micrometer, which was within the specifications of 0.788-0.826mm per product drawing.Fun ctional inspection of the returned guide wire was performed per the product instructions-for-use which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle.Advancement of guidewire through arrow raulerson syringe may require a gentle twisting motion." the returned guide wire was threaded through a lab inventory ars with no resistance.A manual tug test confirmed both welds were intact.The instructions-for-use (ifu) provided with this kit warns 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 with no relevant findings.Based on these circumstances, and without the ars to evaluate, the probable root cause for this event could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that the spring wire j-tip "has dent and almost fracture".The spring wire guide was stuck in the arrow raulerson sy ringe (ars) and could not be removed.The user removed the ars along with the spring wire guide.A new kit was used to complete the procedure.No patient harm was reported.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17258023
• Report Number: 3006425876-2023-00613
• Device Sequence Number: 5885266
• Product Code: DQY
• UDI-Device Identifier: 40801902127745
• UDI-Public: 40801902127745
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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
• Device Model Number: IPN030777
• Device Catalogue Number: CS-15802-E
• Device Lot Number: 71F22D2316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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