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

Catalog Number	CL-07865
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the customer returned one sheath extension assembly with dilator for analysis.Signs of use were observed.Visual inspection revealed the hemostasis cap and valve were separated from the valve body.The dilator was fully inserted through the sheath.No other defects or anomalies were observed.The inner diameter of the hemostasis valve cap was measured and found to be within specification limits.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "hemostasis valve must be occluded at all times to minimize the risk of air embolism or hemorrhage.If device introduction is delayed, or device is removed, temporarily cover valve opening with sterile-gloved finger until catheter or obturator is inserted.Use arrow obturator, either included with this product or sold separately, to occlude sheath.This will ensure that leakage does not occur and inner seal is protected from contamination." the customer report of sheath valve assembly separation was confirmed through investigation of the returned sample.Visual analysis revealed the hemostasis cap and valve were separated from the valve body.The dilator was fully inserted through the sheath.No other defects or anomalies were observed.Dimensional testing of the hemostasis cap passed.Manufacturing, supplier quality, and sustaining engineering were contacted as part of this investigation, and it was determined that this failure mode is attributable to a design issue related to the size of the hemostasis cap.The inner diameter of the cap affects its interaction with the seal.When the seal shifts from its intended position during dilator insertion/removal, this movement may contribute to the separation.A capa is under implementation to address the hemostasis valve cap design.Based on the customer report and sample received, the probable cause is likely design related.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that during the procedure, the operating physician observed that the sheath connection component detached from the device.The affected device was removed and replaced with another device, allowing the procedure to continue without further complication.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: 25447956
• Report Number: 9680794-2026-00437
• Device Sequence Number: 20293755
• 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): 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-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: 05/19/2026
• Initial Report FDA Received Date: 06/09/2026
• 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