MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 9 FR X 4 1/8 IN (10 CM); INTRODUCER, CATHETER

Catalog Number	ASK-09903-YNH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "a kit was opened, revealing that the stopcock connection was not bonded.Upon further inspection, it was noted that the bonding was broken, with one piece lodged inside the catheter.Another kit was subsequently opened, and in this case, the stopcock was bonded properly.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided five images for analysis.Three images showed a defective stopcock/fitting.One image showed the kit lidstock information.The fifth image showed the psi whilst inside the patient.The customer report is confirmed from the photos.The customer also returned one psi sheath assembly and a lidstock.The tray and the rest of the kit contents for this specific assembly were not returned.In addition to this, four unopened kits of the same kit type were also returned.It is assumed that these four unopened kits are representative samples.Visual analysis of the lone psi sheath revealed that the stopcock was separated from the hub of the side arm.A portion of the stopcock was still adhered inside the luer hub.Microscopic examination confirmed the separation and revealed that the edges were jagged and not uniform.White stress marks were also observed.The four representative kits were opened to analyze the psi/stopcock assembly.No defects or anomalies were observed as the stopcock(s) were secure within the luer hub(s).Manufacturing and r & d were contacted as part of this complaint.They confirmed that this damage can occur if there is too much of the glue (dichloromethane) is present on the assembly.This glue reacts with the plastic and degrades the structural integrity.Therefore, it is possible for this defect to occur during manufacturing.Therefore , further investigation needs to be conducted by the manufacturing facility.A device history record review was performed, and no relevant findings were identified.The report of a damaged stopcock was confirmed through complaint investigation.Visual analysis revealed that the stopcock was separated from the side arm of the psi.A portion of the stopcock had separated and was still lodged inside the luer hub.Further confirmation from r & d and manufacturing revealed that this defect can occur during the manufacturing of the psi assembly.Therefore, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "a kit was opened, revealing that the stopcock connection was not bonded.Upon further inspection, it was noted that the bonding was broken, with one piece lodged inside the catheter.Another kit was subsequently opened, and in this case, the stopcock was bonded properly.".

• Brand Name: ARROW PSI KIT: 9 FR X 4 1/8 IN (10 CM)
• 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: 21491701
• Report Number: 9680794-2025-00190
• Device Sequence Number: 3956978
• Product Code: DYB
• UDI-Device Identifier: 10801902118193
• UDI-Public: (01)10801902118193(11)240906(17)261031(10)33F24E0527(21)
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: ASK-09903-YNH
• Device Lot Number: 33F24E0527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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