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

Catalog Number	CL-07065
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "we had an issue with the 10x65 arrow flex sheath.While removing the dilator, the hub of the dilator came off.All items were retained.No harm to the patient".There was no medical intervention required.The patient's current condition is reported as "discharged home.".
Additional Manufacturer Narrative
(b)(4).The customer report of a hub separated from a dilator was confirmed through complaint investigation of the returned sample.The sheath was not returned for analysis.The dilator was separated directly adjacent to the hub.The material at the points of separation showed white discoloration.This discoloration appeared consistent to that of a stress related break.Minor damage was additionally observed to the dilator hub.A device history record review was performed, and no relevant findings were identified.A capa has been previously initiated for this issue.The capa investigation indicates the root cause is design related.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for reports of this nature.

• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20746895
• Report Number: 9680794-2024-01119
• Device Sequence Number: 8362570
• Product Code: DQY
• UDI-Device Identifier: 00801902001726
• UDI-Public: (01)00801902001726(11)221017(17)270930(10)14F22K0069(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• 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
• Report Date (Section B): 10/24/2024

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: CL-07065
• Device Lot Number: 14F22K0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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
• Patient Sex: Unknown