MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 7 FR X 4IN ANTIMICROBIAL; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-09701-UMH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "introducer sheath malfunction during insertion.White catheter separated from the hub after insertion.Affected catheter parts saved." there was no patient harm.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The customer provided one image showing multiple components from a psi kit.Visual analysis revealed that the catheter body is separated.The customer also returned multiple components from a psi kit.Signs of use in the form of biological material were observed inside the sheath side arm and extrusion.Visual analysis revealed that the sheath extrusion was separated adjacent to the hemostasis body.Microscopic examination confirmed the damage and revealed that much of the edges at the point of separation were smooth and uniform; however, a shear mark is visible.No other defects or anomalies were observed on the sheath, the returned dilator, nor guide wire.The point of separation measured 0.027" from the tip of the hemostasis body.The sheath body total length measured 4 1/4", which is within the specification limits of 4"-4 1/4" per the sheath product drawing.The sheath extrusion outer diameter measured 0.1242", which is within the specification limits of 0.1210"-0.1260" per the sheath extrusion product drawing.The sheath inner diameter at the point of separation measured 0.104", which is within the specification limits of 0.103"-0.108" per the sheath extrusion product drawing.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or sheath/dilator assembly as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "do not secure, staple and/or suture directly to outside diameter of device body or extension lines to reduce risk of cutting or damaging the device or impeding device flow.Secure only at indicated stabilization locations.".The report of a sheath body separation was confirmed through complaint investigation.Visual analysis revealed that the sheath body was separated adjacent to the hemostasis body.Shear forces were evident and the sheath body material was distorted at the point of separation indicating a force break.Despite the damage, the sample met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the damage was observed during use and the appearance of the sample, it was determined that unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "introducer sheath malfunction during insertion.White catheter separated from the hub after insertion.Affected catheter parts saved." there was no patient harm.The patient's current condition is reported as "unknown".

• Brand Name: ARROW PSI KIT: 7 FR X 4IN ANTIMICROBIAL
• 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: 23404501
• Report Number: 9680794-2025-00877
• Device Sequence Number: 4902232
• Product Code: FOZ
• UDI-Device Identifier: 10801902139365
• UDI-Public: (01)10801902139365(11)250718(17)270131(10)33F25G0008(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2025

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: ASK-09701-UMH
• Device Lot Number: 33F25G0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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