MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH-LAB SHEATH INTRO SET:; CATHETER PERCUTANEOUS

Catalog Number	CL-07065
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned a cath lab sheath and inserted dilator with the associated packaging.The dilator hub was missing, confirming the complaint.No other damage was observed.A device history review was performed and there were no relevant findings.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary".The customer report of the dilator hub breaking off was able to be confirmed through investigation of the returned product.The unit was returned for investigation, and the hub was missing from the dilator.A capa has been previously initiated for this issue.Based on the capa investigation and returned product, the root cause is likely design related.Corrective actions have not yet been fully implemented.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that the super arrow flex (saf) sheath was inserted, and the proximal end of the dilator hub separated.The operating physician successfully removed the sheath and dilator simultaneously, with no components left within the vessel.The device was replaced with another percutaneous introducer sheath to complete the procedure.There were no reports of patient injury, harm, or adverse health consequences associated with this event.The patient's condition was reported as "fine." no additional medical intervention was required beyond that described.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET:
• 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: angela meister ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 25511669
• Report Number: 9680794-2026-00452
• Device Sequence Number: 16078739
• Product Code: DQY
• UDI-Device Identifier: 10801902200805
• UDI-Public: (01)10801902200805(11)221017(17)270930(10)14F22K0069(21)
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: CL-07065
• Device Lot Number: 14F22K0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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.
• Patient Sex: Unknown