MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 8IN (20 CM); CATHETER PERCUTANEOUS

Catalog Number	CV-04701-BZ
Medical Device Problem Codes	Unraveled Material (1664); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the operating physician that during use of the device, the spring wire guide wire (swg) became "completely tangled" (unraveled).The timing and specific circumstances surrounding the device damage were not provided.It was also reported that the patient required medical interventions, including local compression of the femoral artery, administration of an antifibrinolytic infusion to aid in clot stabilization, and transfusion of fresh frozen plasma (ffp).The device was surgically removed in the operating room.The patient was subsequently discharged from the hospital on (b)(6) 2026.Three follow-up attempts were made to obtain additional details regarding the device failure and patient outcome; however, no further information has been received as of the date of this report.
Additional Manufacturer Narrative
Continuation of d11: aid in clot stabilization, and transfusion of fresh frozen plasma (ffp).(b)(4).

• Brand Name: ARROW CVC SET: 14 GA X 8IN (20 CM)
• 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: 25436338
• Report Number: 9680794-2026-00431
• Device Sequence Number: 13346122
• Product Code: OWL
• UDI-Device Identifier: 10801902185027
• UDI-Public: (01)10801902185027(11)251029(17)300930(10)14F25K0297(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: CV-04701-BZ
• Device Lot Number: 14F25K0297
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2025
• 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: ADMINISTRATION OF AN ANTIFIBRINOLYTIC INFUSION TO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown