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	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: " on (b)(6) 2025, during the placement of product, blood leakage was observed both inside and outside the sheath protective sleeve, which delayed the treatment time.Involved 1 pc.".
Additional Manufacturer Narrative
(b)(4).The customer report of a sheath valve leak was confirmed through investigation of the returned sample.The customer returned one opened psi sheath, 7fr swan-ganz catheter, and a cath-gard for analysis.Functional leak testing of the device in accordance with required specification did not reveal any leaks or anomalies of any kind; however, aspiration testing revealed that air-bubbles form when the inserted component is held at an angle.Consultation from r & d unit revealed angled catheters can contribute to the customer observing air-bubbles during aspiration.A device history record review was performed, and no relevant findings were identified.The returned 7fr catheter is compatible with the reported device however, it is unknown, at the time of the event, the orientation of the catheter relative to the hemostasis valve.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2025, during the placement of product, blood leakage was observed both inside and outside the sheath protective sleeve, which delayed the treatment time.Involved 1 pc.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23943815
• Report Number: 3006425876-2026-00006
• Device Sequence Number: 21522176
• Product Code: DYB
• UDI-Device Identifier: 00801902102874
• UDI-Public: (01)00801902102874(11)230920(17)280128(10)71F23J0591(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/12/2025

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: SI-09880
• Device Lot Number: 71F23J0591
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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