MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-3/4IN; CATHETER PERCUTANEOUS

Catalog Number	RA-04020-SP
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "srna initially attempted to place l radial arterial line via ultrasound guidance.He walked in the arrow via us, got arterial flash, and easily threaded the wire.However, the srna then realized that he could not retract the arrow from the catheter.Crna attempted and immediately confirmed resistance to withdrawing the arrow, so the attending md and surgical team were alerted to the issue.We also called the mce aic into the or.Under us guidance, the md & aic were able to successfully remove the intact arrow and catheter, which was significantly bent.There was no evidence of hematoma, perfusion compromise, or remaining components in the artery via us imaging.Md subsequently placed a radial art via us on the rue." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.Visual analysis showed that the catheter was crimped on a kinked guide wire.Therefore, the customer report was confirmed; 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 ifu provided with the kit informs the user, "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 "srna initially attempted to place l radial arterial line via ultrasound guidance.He walked in the arrow via us, got arterial flash, and easily threaded the wire.However, the srna then realized that he could not retract the arrow from the catheter.Crna attempted and immediately confirmed resistance to withdrawing the arrow, so the attending md and surgical team were alerted to the issue.We also called the mce aic into the or.Under us guidance, the md & aic were able to successfully remove the intact arrow and catheter, which was significantly bent.There was no evidence of hematoma, perfusion compromise, or remaining components in the artery via us imaging.Md subsequently placed a radial art via us on the rue." 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 1-3/4IN
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 23094984
• Report Number: 9680794-2025-00771
• Device Sequence Number: 8617977
• Product Code: DQY
• UDI-Device Identifier: 00801902027528
• UDI-Public: (01)00801902027528(11)250520(17)300430(10)14F25D0166(21)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• 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): 08/25/2025

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 Catalogue Number: RA-04020-SP
• Device Lot Number: 14F25D0166
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2025
• 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