MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1 1/2IN; WIRE GUIDE CATHETER

Catalog Number	RA-04220-W
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "while a resident was placing an a-line the arrow needle perforated through the cannula and became jammed." a new device was used.There was no patient harm or injury.The patient's current condition is reported as "unknown but probably discharged/stable".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The photos show the catheterization device with the distal end of catheter and guide wire appearing bent with the needle bevel punctured through the catheter body.The condition of the device suggests the customer punctured the catheter with the needle, and the catheter and guide wire were kinked in the same event, however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.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, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel.Precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "while a resident was placing an a-line the arrow needle perforated through the cannula and became jammed." a new device was used.There was no patient harm or injury.The patient's current condition is reported as "unknown but probably discharged/stable".

• Brand Name: ARROW RA CATH SET: 20 GA X 1 1/2IN
• Common Device Name: WIRE GUIDE CATHETER
• 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: 21824115
• Report Number: 9680794-2025-00286
• Device Sequence Number: 4211002
• Product Code: DQX
• UDI-Device Identifier: 00801902101501
• UDI-Public: (01)00801902101501(11)240301(17)290228(10)13F24B0007(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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
• Device Catalogue Number: RA-04220-W
• Device Lot Number: 13F24B0007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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