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

Catalog Number	RA-04220
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "tip broke off in patient artery.Patient had arterial line inserted in ed, following the patient procedures, pacu nurse removed arterial line from patient, tip of the arterial cannula was missing and left in the patient's radial artery.Vascular medical team was consulted and reported no need to retrieve tip of arterial cannula from patient radial artery.Pacu nurse informed treating anaesthetist, neurovascular observations and ongoing monitoring of the patient.Ultrasound was used to determine if tip present in artery (was confirmed), anaesthetist contacted gen surgical and vascular team for consult.No further intervention/exploration.Patient continued to monitor nvo overnight." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn #: (b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of catheter separated during use cannot be confirmed by the photo as it only reveals the lidstock of the product.No visual evidence of the catheter separation was provided.Additionally, a complete visual inspection 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: do not use excessive force in removing catheter.If resistance is met on removal, stop and follow institutional policies and procedures for difficult to remove catheters." 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 "tip broke off in patient artery.Patient had arterial line inserted in ed, following the patient procedures, pacu nurse removed arterial line from patient, tip of the arterial cannula was missing and left in the patient's radial artery.Vascular medical team was consulted and reported no need to retrieve tip of arterial cannula from patient radial artery.Pacu nurse informed treating anaesthetist, neurovascular observations and ongoing monitoring of the patient.Ultrasound was used to determine if tip present in artery (was confirmed), anaesthetist contacted gen surgical and vascular team for consult.No further intervention/exploration.Patient continued to monitor nvo overnight." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW RA CATH SET: 20 GA X 1-1/2 IN
• 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: 21967520
• Report Number: 9680794-2025-00375
• Device Sequence Number: 20920464
• Product Code: DQX
• UDI-Device Identifier: 00801902002761
• UDI-Public: (01)00801902002761(11)240514(17)290430(10)14F24E0085(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: RA-04220
• Device Lot Number: 14F24E0085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2024
• 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