MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 8.5 FR; INTRODUCER, CATHETER

Catalog Number	IC-09880
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "upon removing the introducer needle from the cordis, blood is flowing from it." the user changed to a new set.There was no patient harm or injury.The patient's current condition is reported as "unknown".
Event or Problem Description
It was reported "upon removing the introducer needle from the cordis, blood is flowing from it." the user changed to a new set.There was no patient harm or injury.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4) the customer provided one photo for analysis.The image shows a psi sheath and a dilator with obvious signs of use.The complaint of a leak could not be confirmed from just the image.The customer also returned one opened psi sheath and dilator for evaluation.Signs of use were observed on the returned components.Visual inspection of the returned sample did not reveal any defects or anomalies.The sheath sidearm was flushed using a lab inventory 20ml syringe.Water was observed exiting the sheath distal end and leaking from the valve.The hemostasis valve and psi was leak tested per amrq-000037 rev12.Low pressure leak resistance (hemostasis valve), section 6.1.2, which states, "using a test pressure of 38-42 kpa (5.51-6.09 psi), there shall be no leakage past the hemostasis valve".The mac catheter was attached to a lab leak tester.With the distal end of the sheath occluded, the sheath was pressurized to 42 kpa for 30 seconds.Leaking was observed from the hemostasis valve, which confirms the report of leaking.A lab inventory dilator was advanced through the sheath.The dilator was able to be removed and reinserted with no resistance.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." the customer report of a sheath valve leak was confirmed through investigation of the returned sample.Functional inspection revealed a leak at the location of the hemostasis valve when the psi was pressurized with water.Based on the customer report and the functional inspection, manufacturing likely caused or contributed to this issue.A non-conformance was initiated to further analyze this issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW PSI SET: 8.5 FR
• Common Device Name: INTRODUCER, CATHETER
• 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: 22308610
• Report Number: 9680794-2025-00520
• Device Sequence Number: 8081331
• Product Code: DYB
• UDI-Device Identifier: 00801902100672
• UDI-Public: (01)00801902100672(11)241107(17)291031(10)14F24K0136(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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
• Device Catalogue Number: IC-09880
• Device Lot Number: 14F24K0136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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