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 Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an attempted arterial catheter insertion, the procedure was unsuccessful.Upon removal of the catheter, it was observed that a portion of the catheter was missing, indicating catheter fracture and retention within the patient.As a result, the patient underwent an exploratory arteriotomy to retrieve the retained catheter fragment.The fragment was successfully removed during the originally scheduled surgical/anesthesia period.The patient was discharged on the same day without reported complications or adverse sequelae.

• 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: 25696161
• Report Number: 9680794-2026-00508
• Device Sequence Number: 15870601
• Product Code: OFK
• UDI-Device Identifier: 00801902027528
• UDI-Public: (01)00801902027528(11)250707(17)300630(10)14F25E0193
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 14F25E0193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown