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

Catalog Number	SI-09880
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the injection of saline solution revealed that there was liquid leakage at the white sealed connector." the device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the injection of saline solution revealed that there was liquid leakage at the white sealed connector." the device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided three photos for analysis.The photos show the psi sheath with the hemostasis valve body circled.Neither an indwelling catheter nor an obturator were pictured with the hemostasis valve body; however, it is unknown if such components were removed prior to the defect being observed.No evidence of a leak can be observed in the provided photos, however, a complete visual inspection could not be performed as no sample was returned for analysis.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, "warning: hemostasis valve must be occluded at all times to reduce the risk of air embolism, contamination or hemorrhage.In the absence of an indwelling central catheter use the arrow obturator to occlude hemostasis valve." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for 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 CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21813788
• Report Number: 3006425876-2025-00344
• Device Sequence Number: 9009497
• Product Code: DYB
• UDI-Device Identifier: 00801902102874
• UDI-Public: (01)00801902102874(11)230818(17)270728(10)71F23H0914(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K780532
• 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): 03/19/2025

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
• Device Catalogue Number: SI-09880
• Device Lot Number: 71F23H0914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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