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

Catalog Number	CV-47702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor 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).
Event or Problem Description
It was reported that "the doctor 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 a guidewire, advancer, ars, 2-lumen catheter, transduction probe, and lid stock for evaluation.Signs of use were observed on the returned components.The guidewire was observed to have two kinks in the middle of the body.The distal j-bend was intact.Microscopic examination confirmed the kinks in the guidewire body.Both welds were present and were observed to be full and spherical.The kinks on the guidewire were measured at 535mm and 543mm from the proximal weld.The overall length of the guidewire measured 598mm, which is within the specification of 596mm - 604mm per the guidewire product drawing.The outer diameter of the guidewire measured 0.80mm, which is within the specification of 0.788mm - 0.826mm per guidewire product drawing.The guidewire testing was performed per ifu statement, "using thumb, retract "j".Place tip of arrow advancer - with "j" retracted - into the hole in rear of arrow raulerson syringe plunger or introducer needle.Advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guidewire was advanced through the returned ars and 18ga needle.The guidewire faced major resistance going through the assembly at the location of the kinks.However, no resistance was encountered at the undamaged portions of the 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 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 of a kinked guidewire was confirmed through visual analysis of the returned sample.The guidewire was kinked at two locations in the middle of the body.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.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21547994
• Report Number: 3006425876-2025-00238
• Device Sequence Number: 14613202
• Product Code: FOZ
• UDI-Device Identifier: 10801902102536
• UDI-Public: (01)10801902102536(11)240326(17)251108(10)71F24C0966(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993691
• 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): 02/19/2025

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 Expiration Date: 11/08/2025
• Device Catalogue Number: CV-47702-E
• Device Lot Number: 71F24C0966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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