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

Catalog Number	CL-07880
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "on (b)(6) 2026, the sheath valve leak during use on the patient.After confirmed with the customer.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a sheath valve leak was able to be confirmed through investigation of the returned sample.The customer returned one sheath extension assembly with dilator for analysis.Initial testing per the applicable test method requirement passed at 40 kpa but failed at 20 kpa.After fully compressing the seal into the hemostasis valve body using the dilator tip, no leakage was observed at either pressure.However, after dilator insertion and removal caused the seal to protrude from the valve, leakage was observed again at both 40 kpa and 20 kpa.Further evaluation showed the seal shifted from its original position during dilator use and remained visibly protruding after removal.One seal slit appeared shorter than the others, with dimensional analysis confirming multiple slit dimensions outside specification limits.No other defects or anomalies were observed.Based on the investigation with manufacturing, supplier quality, and sustaining engineering, the failure mode was attributed to a design issue related to the hemostasis cap inner diameter, which affects seal retention and interaction.Seal slit dimensions may also have contributed to seal movement and resulting leakage.The cap design likely contributes to the seal movement and the resulting leak.Additionally, seal slit dimensions were found to be out of specification, which was attributed to the supplier.This issue may also have contributed to seal movement and, consequently, the leakage.A capa has been opened under teleflex quality systems to address this issue with cap design.
Event or Problem Description
It was reported that: "on (b)(6) 2026, the sheath valve leak during use on the patient.After confirmed with the customer.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24504527
• Report Number: 9680794-2026-00159
• Device Sequence Number: 9869965
• Product Code: DQY
• UDI-Device Identifier: 00801902002020
• UDI-Public: (01)00801902002020(11)240514(17)290430(10)14F24E0013(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 02/09/2026

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-07880
• Device Lot Number: 14F24E0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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.; NOT REPORTED.
• Patient Sex: Unknown