MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS

Catalog Number	CS-24706-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found the swg kinked prior to the patient".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows the distal tip of the guide wire with kinking towards the j-bend within the thumb guide.The customer also returned one opened cvc kit including one guide wire within its advancer and an arrow raulerson syringe (ars) for analysis.The guide wire cap was not returned.Signs of use were observed, and the customer confirmed the sample was contaminated within the clinical setting.The guide wire was observed to have multiple kinks and one bend on the guide wire body.The distal j-bend was misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.During full assembly, the kinking in the guide wire would have been located within the guide wire cap during packaging, shipping, and storage, protecting it from damage.No other defects or anomalies were observed on the returned guide wire assembly.The kinks in the guide wire were located 10 mm and 44 mm from the distal tip.The bend in the guide wire was located 130 mm from the proximal tip.The overall length of the guide wire measured 456 mm, which is within the specification limits of 450-458 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.793 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 the returned 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 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 was kinked was confirmed through complaint investigation of the returned sample.Multiple kinks were observed on the guide wire body.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.During normal assembly, a kinked portion of the guide wire would be protected within the guide wire cap of the advancer assembly, however, the guide wire cap was missing from the returned assembly.Based on the customer report and sample received, the potential root cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "the doctor found the swg kinked prior to the patient".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.

• Brand Name: ARROW CVC SET: 14 GA X 6" (16 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: 21167491
• Report Number: 3006425876-2025-00106
• Device Sequence Number: 4275842
• Product Code: DQY
• UDI-Device Identifier: 10801902102291
• UDI-Public: (01)10801902102291(11)231215(17)251109(10)71F23M0556(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2025
• Device Catalogue Number: CS-24706-E
• Device Lot Number: 71F23M0556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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