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	01/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found sheath hub external leak during used on the patient.".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.
Event or Problem Description
It was reported that "the doctor found sheath hub external leak during used on the patient.".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one sheath extension assembly for analysis.The dilator was not returned.Signs of use were observed.Visual analysis revealed no obvious defects of anomalies.The seal within the hemostasis hub appeared intact.The length of the sheath body measured 31 9/16" which is within the specification limits of 30 7/8"- 31 7/8" per sheath extension assembly product drawing.The outer diameter of the sheath measured 0.1370" which is within spec of 0.135"-0.140" per sheath extension assembly product drawing.The inner diameter of the distal tip of the sheath measured 0.1085" which is within spec of 0.108"-0.110" per sheath extension assembly product drawing.Functional testing of the returned sheath was first performed per the instructions for use (ifu) provided with this kit.The ifu states "prepare sheath for insertion by flushing through side arm." a lab inventory syringe filled with water was used to flush the sidearm with water.No leaking was observed.The returned sheath was also tested per the module requirements document for super arrow-flex sheath introducer.1.) the low pressure leak resistance (hemostasis valve) requirement states "when tested in accordance with iso 11070:, annex e, using a test pressure of 38-42kpa (5.51-6.09psi), there shall be no leakage past the hemostasis valve." the sidearm of the sheath was connected to the lab leak tester, and the distal tip of the sheath was clamped.The sheath was tested at a pressure of 40 kpa for 30 seconds.No leaking was observed.2.) the high pressure leak resistance (sheath extension assembly) requirement states "when tested in accordance with iso 11070: , annex d, using a test pressure of 300-320 kpa (43.5 - 46.4 psi) there shall be no leakage sufficient to form a falling drop." the sidearm of the sheath was connected to the lab leak tester, and the distal tip of the sheath was clamped.The hemostasis hub was occluded using a lab inventory dilator and luer cap.Leaking was observed from the connection between the sidearm extension tubing and the hemostasis hub.Note: damage to the distal tip of the sheath was sustained during functional testing due to necessary clamping.This damage is not relevant to the findings of this investigation.A device history record review was performed, and no relevant findings were identified.The customer complaint of a sheath hub leak was able to be confirmed through investigation of the returned sample.Functional testing of the returned sheath revealed leaking between the sidearm extension tubing and hemostasis hub.Despite this, the returned sheath passed all dimensional requirements.Based on the functional testing, manufacturing caused or contributed to the reported event.A non-conformance has been initiated to further investigate this issue at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21548106
• Report Number: 9680794-2025-00213
• Device Sequence Number: 4420120
• Product Code: DQY
• UDI-Device Identifier: 00801902002020
• UDI-Public: (01)00801902002020(11)231107(17)281031(10)14F23K0387(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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-07880
• Device Lot Number: 14F23K0387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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; NOT REPORTED
• Patient Sex: Unknown