MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 4.5FR X 7CM GLIDETHRU SHEATH/DILATOR; INTRODUCER CATHETER

Catalog Number	PL-00745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "inserters feared they lost in patient but it was recovered.Told they are incredibly flimsy." no medical intervention reported.The patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of peel-away sheath tears incorrectly was able to be confirmed by the photos.A device history record review was performed, and there were two potential findings.Two non-conformances were initiated for lot# 34c23f0030 in regard to "peel-away sheath tears incorrectly".Based on the customer provided photos and relevant dhr findings, manufacturing likely caused or contributed to the failure mode of this complaint.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding." the customer report of peel-away sheath tears incorrectly was confirmed by visual inspection of the customer supplied photos.A device history record review was performed, and two relevant complaints/non-conformances were identified for the extrusion batch within the reported kit.Based on the customer provided photos and relevant dhr findings, manufacturing likely caused or contributed to th is event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "inserters feared they lost in patient but it was recovered.Told they are incredibly flimsy." no medical intervention reported.The patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.

• Brand Name: ARROW 4.5FR X 7CM GLIDETHRU SHEATH/DILATOR
• 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: 17798143
• Report Number: 9680794-2023-00746
• Device Sequence Number: 14874504
• Product Code: DYB
• UDI-Device Identifier: 00801902080257
• UDI-Public: 00801902080257
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K122854
• 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): 08/28/2023

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 Expiration Date: 05/31/2025
• Device Catalogue Number: PL-00745
• Device Lot Number: 14F23E0261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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