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

Catalog Number	CL-07865
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the operating physician observed that the rubber packing component separated and fell out of the device.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 reported beyond removal of the affected device, and replacement with another device.Good faith efforts were made to obtain additional information regarding the reported device issue.A total of three documented attempts were made to contact the user facility; however, no response or additional information was received.
Additional Manufacturer Narrative
(b)(4).One returned sample, consisting of a dilator and sheath interlocked together, was received for evaluation.Examination revealed that the seal had been pulled out of the cap but remained on the shaft of the dilator body.Additionally, the seal exhibited damage, including a puncture at a separate location that resulted in a tear.A historical review identified a similar issue documented under a previously opened capa.That investigation attributed the failure to a design-related issue, specifically an oversized cap inner diameter, which can allow the seal to partially or completely dislodge from the sheath hub.Based on the evaluation of the returned product and the documented history, the most probable root cause of this issue is design related.Teleflex will continue to monitor similar complaints and trends.

• 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: 25477453
• Report Number: 9680794-2026-00480
• Device Sequence Number: 9165409
• Product Code: DQY
• UDI-Device Identifier: 10801902200850
• UDI-Public: (01)10801902200850(11)231117(17)281031(10)14F23L0080(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K862056
• 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
• Report Date (Section B): 06/08/2026

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-07865
• Device Lot Number: 14F23L0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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