MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-24301-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the nurse found the swg kinked during used on 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 returned one cvc kit, including the guidewire assembly, 1-lumen catheter, 18ga introducer needle, arrow raulerson syringe (ars), and dilator for evaluation.Evidence of use was observed on the returned components.The guidewire was observed to contain multiple kinks in the middle of the body and near the distal end.The distal j-bend was misshapen.Microscopic examination confirmed the kinks in the guidewire body.Both distal and proximal welds were present and were observed to be full and spherical.The guidewire kinks measured 260mm, 275mm, and 567mm from the proximal end.The guidewire length measured 600mm, which is within the specification limits of 596mm - 604mm per the guidewire product drawing.The guidewire outer diameter measured 0.800mm, which is within the specification limits of 0.788mm-0.826mm per the guidewire product.The guidewire was advanced through the returned 18ga introducer needle/ars subassembly.No resistance was encountered at the undamaged portions of the guidewire.Resistance was experienced at the kinked locations.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the returned catheter was then threaded over the guidewire.No resistance was encountered at the undamaged portions of the guidewire.Resistance was encountered at the kinked locations.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." a manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guidewire was confirmed through visual analysis of the returned sample.The guidewire contained multiple kinks towards the middle of the body and distal end.The returned guidewire 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 guidewire and the report that the damage was observed during use, unintentional use error 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 that "the nurse found the swg kinked during used on 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: 16 GA X 8" (20 CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 21167647
• Report Number: 3006425876-2025-00107
• Device Sequence Number: 13114840
• Product Code: FOZ
• UDI-Device Identifier: 00801902102225
• UDI-Public: (01)00801902102225(11)240429(17)260331(10)71F24D1093(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/30/2024

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: 03/31/2026
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F24D1093
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• 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: 04/29/2024
• 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