MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Model Number	IPN921140
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the catheter could be advanced through the sheath, but could only be withdrawn with great difficulty." there was no patient complications.No medical intervention required.The procedure was completed successfully.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one cath-lab sheath and dilator.Signs of use in the form of blood particulates were noted.The valve of the sheath was damaged and torn.There was damage to the dilator tip.No other defects were noted on the unit.Dimensional inspection of the valve seal was performed using the product drawing.The slits were torn but measurements were taken from the center up to the tears on the three slits.They measured at 0.58 mm, 0.56 mm, and 0.60 mm which are all below the specification limits.The outer diameter measured at 8.25 mm which is within specification limits.The valve thickness was 1.30 mm which was within specification limits.Device was functionally tested per the instructions for use (ifu).The dilator was inserted through the valve but experienced severe resistance and ultimately could not advance through the sheath.The sheath was flushed through sidearm without leaking and with the dilator in.A device history record review was performed and there was one relevant finding for the seal with lot number 14p23m0089.A non-conformace was created for the slits on the valve being too small.The ifu cautions the user "ensure dilator hub fully snaps into sheath cap." the customer complaint of the dilator being tight in the sheath was confirmed through investigation of the returned sample.Visual analysis revealed damage of the valve in the form of tearing.The dilator tip was also damaged.It's unclear when or how the tip damage occurred.Functional testing revealed that the dilator could not be advanced or removed in the sheath without severe resistance.Dimensional analysis revealed the slits on the internal seal were not within specification measuring at 0.58 mm, 0.56 mm, and 0.60 mm.Based on the customer report and the sample received, the root cause is supplier related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "the catheter could be advanced through the sheath, but could only be withdrawn with great difficulty." there was no patient complications.No medical intervention required.The procedure was completed successfully.The patient's current condition is reported as "unknown".

• Brand Name: ARROW CATH LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 23025949
• Report Number: 9680794-2025-00755
• Device Sequence Number: 9329098
• Product Code: DQY
• UDI-Device Identifier: 00801902001856
• UDI-Public: (01)00801902001856(11)240429(17)290331(10)14F24D0270(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: IPN921140
• Device Catalogue Number: CL-07645
• Device Lot Number: 14F24D0270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• 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