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

Catalog Number	CL-07780
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2025, during the interventional procedure, director from the respiratory interventional department of (b)(6) hospital found the sheath valve was leaking.The patient was reported as fine.Involved 1 pc.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported sheath valve leak was confirmed through evaluation of the returned sample, which included one sheath extension assembly and dilator.Visual inspection identified deformation at the sheath tip and an internal obstruction.The hemostasis valve seal appeared properly aligned.Functional testing showed the dilator was able to pass through the seal, revealing additional tears, with no other obvious defects observed.Initial flushing per the approved requirement was unsuccessful, and leakage was noted at the hemostasis valve when excessive syringe pressure was applied.After the dilator was used to remove blood clots from the sheath, flushing was repeated with no leak observed.Leak testing per the applicable internal functional requirement was initially successful with no leakage.However, upon repeat testing after dilator insertion, leakage was observed from the hemostasis valve.This is likely due to the dilator expanding or opening existing tears in the seal, allowing fluid to escape.Repeat testing with the dilator in place again resulted in leakage.Dimensional analysis showed the seal slit lengths were below specification limits.A review of device history records identified prior documented issues related to undersized seal slits for the same lot, consistent with the findings in this complaint.The undersized slits likely contributed to increased friction during dilator insertion, leading to additional tearing and subsequent leakage.The damage seen on the seal is consistent with this as the slits lengthened and new tears formed between them.Based on the investigation, it was determined that this damage is likely supplier related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.
Event or Problem Description
It was reported that: "(b)(6) 2025, during the interventional procedure, director from the respiratory interventional department of china-japan friendship hospital found the sheath valve was leaking.The patient was reported as fine.Involved 1 pc.".

• 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: 23987806
• Report Number: 9680794-2026-00045
• Device Sequence Number: 19974840
• Product Code: DQY
• UDI-Device Identifier: 00801902001948
• UDI-Public: (01)00801902001948(11)240913(17)290831(10)14F24J0091(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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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-07780
• Device Lot Number: 14F24J0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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