MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 2-L 8 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-42802-XP1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "coil end of wire was broken off inside of patient." additional information received reports " patient had to undergo a subsequent procedure in order to remove the end of the wire that was retained inside of them." the patient's current condition is unknown at this time.
Additional Manufacturer Narrative
(b)(4) corrected data: section d.4.-catalog# corrected to cdc-42802-xp1a section d.4.-unique identifier (udi)# corrected to (b)(4).The customer returned one guidewire and catheter for analysis.The guidewire advancer was also returned.The guidewire was returned outside of the catheter.The guidewire and catheter showed evidence of use in the form of dried biological material.Visual examination revealed the guidewire was unraveled from the distal weld.There were also one kink towards the proximal end of the guidewire body.The distal j-bend was returned intact and properly shaped.The spring coil was still attached near the distal end.Microscopic examination of the guidewire confirmed that the core wire was broken adjacent to the distal weld.Both welds were present and appeared full and spherical.The proximal weld was still intact.The kink the guidewire body measured at 260mm from the proximal end.The overall length of the core wire measured 601mm, which is within the specification limits of 596mm-604mm per guidewire product drawing.Therefore, no pieces of the core wire were missing.The outer diameter of the guidewire measured 0.810mm, which is within the specification limits of 0.788mm-0.826mm per guide wire product drawing.The returned guidewire and catheter were functionally tested per the instructions for use (ifu) provided with this kit.The undamaged portion of the proximal end was used for functional testing.The ifu states , "thread tip of catheter over guidewire.Advance catheter with slight twisting motion into final indwelling position".The undamaged portion of the returned guidewire was able to advance through the returned catheter with minimal resistance observed.No functional issues were identified with the undamaged portions of the devices.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu warns 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.Warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guidewire unraveled during use was confirmed through examination of the returned sample.Visual examination revealed that the guidewire was unraveled from the distal weld.The distal j-bend was returned intact and properly shaped.The spring coil was still attached at the distal end.The guide wire met all relevant dimensional and functional requirements during investigation testing.No findings were identified that would indicate a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely 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 "coil end of wire was broken off inside of patient." additional information received reports " patient had to undergo a subsequent procedure in order to remove the end of the wire that was retained inside of them." the patient's current condition is unknown at this time.

• Brand Name: ARROW PI CVC KIT: 2-L 8 FR X 16 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: 21908635
• Report Number: 9680794-2025-00348
• Device Sequence Number: 8794709
• Product Code: FOZ
• UDI-Device Identifier: 10801902117110
• UDI-Public: (01)10801902117110(11)241216(17)251231(10)33F24J0261(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: CDC-42802-XP1A
• Device Lot Number: 33F24J0261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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