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

Catalog Number	CV-17702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2025, (b)(6) center, second affiliated hospital of (b)(6) university, the doctor found swg kinked prior to the patient." the user changed to a new set to resolve the issue.
Additional Manufacturer Narrative
(b)(4).The customer provided three photos for analysis.The photos show a kinked guidewire proximal to the j-bend within the assembly and the opened kit.The customer also returned one opened (b)(4) kit set for analysis.No signs of use were observed.The returned guidewire was partially within the advancer and kinked proximal to the j-bend.The cap was not present with the returned sample.Microscopic examination confirmed the kinks in the guidewire body.Both welds were present and were observed to be full and spherical.No other defects or anomalies were observed on the returned guide wire assembly.During full assembly, the kinking in the guidewire would have been located within the guidewire cap during packaging , shipping, and storage, protecting it from damage.The kinks on the guide wire measured 15mm-40mm from the distal tip.The guide wire length measured 599 mm, which is within the specification limits of 596-604mm per guide wire product drawing.The guide wire outer diameter measured 0.800 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, "if using standard arrow advancer, raise thumb and pull arrow advancer approximately 4 - 8 cm away from arrow raulerson syringe or introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into syringe barrel to further advance guidewire.Continue until guidewire reaches desired depth." the guide wire was advanced through a lab inventory ars to functionally test the guide wire.The undamaged portions of the guide wire passed through 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 this kit warns the user , "do not use if package is damaged." the report that the guidewire was kinked was confirmed through complaint investigation of the returned sample.Kinking was observed on the j-bend of the guidewire body.The guidewire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.During normal assembly, the kinked portion of the guidewire would be protected within the guidewire cap of the advancer assembly; however, the guidewire 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 "(b)(6) 2025, (b)(6), the doctor found swg kinked prior to the patient." the user changed to a new set to resolve the issue.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 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: 23278853
• Report Number: 3006425876-2025-00938
• Device Sequence Number: 5469823
• Product Code: DQY
• UDI-Device Identifier: 00801902105455
• UDI-Public: (01)00801902105455(11)240510(17)290430(10)71F24D1135(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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 Catalogue Number: CV-17702-E
• Device Lot Number: 71F24D1135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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