MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR X 4IN (10 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-09804-CCH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the side port of an introducer completely popped off from the introducer into two pieces.The catheter had been in place for six days when the side port "popped off." another catheter was re-inserted to resolve the issue.The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4) the customer returned one psi sheath for analysis.Signs of use in the form of biological material were observed on and within the device.Visual analysis revealed that the sheath sidearm was completely separated from the hemostasis valve body.Indentations were visible on the sidearm extrusion at the point of separation.The sheath sidearm outer diameter measured 0.2085", which is within the specification limits of 0.208"-0.212" per the sidearm extrusion graphic.The sheath sidearm inner diameter at the hub end measured 0.129", which is within the specification limits of 0.128"-0.132" per the sidearm extrusion graphic.The smaller and larger outer diameter of the hemostasis valve body at the connection site with the sidearm were measured.The larger outer diameter measured 0.1955", which is not within the specification limits of 0.198"-0.202".The smaller outer diameter measured 0.1545", which is within the specification limits of 0.1540"-0.159" per the hemostasis valve body drawing.Manufacturing was contacted as a part this complaint investigation.They confirmed the defect is due to a known manufacturing issue and a change was implemented on 22-july-2024 to increase the tooling dimensions on the hemostasis valve body connection site to improve the connection with the sidearm.The sheath involved with this complaint was manufactured 06-july-2024, which is prior to this implementation date.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "do not apply excessive force in placing or removing guidewire, dilator, or sheath.Excessive force can cause component damage or breakage." the customer report of a sheath sidearm separation was confirmed through complaint investigation of the returned sample.The hemostasis valve body, which connects to the sidearm, failed dimensional testing.The connection site for the sidearm to the body was undersized which could have contributed to the separation of the sidearm.Based on these circumstances, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that the side port of an introducer completely popped off from the introducer into two pieces.The catheter had been in place for six days when the side port "popped off." another catheter was re-inserted to resolve the issue.The patient had no harm or injury.

• Brand Name: ARROW PSI KIT: 8.5 FR X 4IN (10 CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 21178712
• Report Number: 9680794-2025-00012
• Device Sequence Number: 8537543
• Product Code: FOZ
• UDI-Device Identifier: 10801902141023
• UDI-Public: (01)10801902141023(11)240909(17)260611(10)33F24D0899(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2026
• Device Catalogue Number: ASK-09804-CCH
• Device Lot Number: 33F24D0899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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