MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45703-XP1A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "emergency room at (b)(6) used a ergp pack that had a defective guidewire.Guidewire kinked during insertion.Apparently, this happened one other time as well." additional information was requested from the customer; however, further details could not be provided at this time.Associated mdr numbers include: 9680794-2025-00720 and 9680794-2025-00721.
Additional Manufacturer Narrative
Qn #: (b)(4).
Event or Problem Description
It was reported "er at (b)(6) used a ergp pack that had a defective guidewire.Guidewire kinked during insertion.Apparently, this happened one other time as well." additional information was requested from the customer; however, further details could not be provided at this time.Associated mdr numbers include: 9680794-2025-00720 and 9680794-2025-00721.
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire and product lidstock for analysis.Signs of use were observed on the guidewire.The guidewire was observed to have a kink towards the center of the body.The distal j-bend was not misshapen and was intact.Microscopic examination confirmed the kink in the guidewire body.Both welds were present and were observed to be full and spherical.The kink in the guidewire was located 371mm from the proximal tip.The overall length of the guide wire measured 602mm which is within the specifications of 596mm - 604mm per guidewire product drawing.The outer diameter of the guidewire measured 0.79mm, which is within the specification of 0.788mm - 0.826mm per guidewire product drawing.The guidewire was advanced through a lab inventory arrow raulerson syringe (ars) and a lab inventory 18ga introducer needle to functionally test the guidewire.Resistance was met at the site of kinking; however , the undamaged portions of the guidewire passed through both components with little to no resistance.Performed per the instructions for use (ifu) statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." 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 guidewire kinked during use was confirmed through examination of the returned sample.The guidewire had one kink towards the center of the body.The returned guidewire met all relevant dimensional/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 PI CVC KIT: 3L 7 FR X 20 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22912598
• Report Number: 9680794-2025-00720
• Device Sequence Number: 9055090
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: (01)20801902117216(11)250202(17)251231(10)36F25A0021(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 36F25A0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2025
• 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