MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-26702-E
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	03/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during insertion on the left jugular, the guidewire did not go through the arrow raulerson syringe (ars).No patient harm reported.A new set was used on the left subclavian vein successfully.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#: (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The report of a kinked guide wire due to catheter resistance was confirmed through complaint investigation.The customer returned one, opened cvc kit for analysis.Signs-of-use in the form of biological material were observed.Visual analysis revealed that the guide wire was returned inserted through the catheter body.The guide wire was removed, and two obvious kinks were observed.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kinks on the guide wire measured 384mm and 446mm from the proximal weld.The guide wire total length measured 603mm, which was within the specification limits of 596mm-604mm per the guide wire product drawing.The kinks and the guidewire total length were measured via calibrated ruler.The guide wire outer diameter measured 0.790mm via calibrated caliper, which was within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The catheter length measured 215mm via calibrated ruler, which was within the specification limits of 207mm-227mm per the catheter product drawing.The catheter body outer diameter measured 2.43mm via calibrated caliper, which was within the specification limits of 2.36mm-2.46mm per the catheter body extrusion product drawing.Functional inspection was performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".The guide wire was removed from the catheter body.Slight resistance was encountered due to the kinking on the guide wire.A lab inventory guide wire was then reinserted through the catheter.Little to no resistance was countered as the guide wire passed completely through the assembly.A manual tug test confirmed that the distal and proximal welds were secure and 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 per formed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely 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 during insertion on the left jugular, the guidewire did not go through the arrow raulerson syringe (ars).No patient harm reported.A new set was used on the left subclavian vein successfully.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17510435
• Report Number: 3006425876-2023-00837
• Device Sequence Number: 7944091
• Product Code: FOZ
• UDI-Device Identifier: 10801902102352
• UDI-Public: 10801902102352
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K900263
• 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): 08/09/2023

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: 06/14/2024
• Device Catalogue Number: CS-26702-E
• Device Lot Number: 71F22F5394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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