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

Catalog Number	CL-07024
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "hub broke off the sheath dilator/introducer during initial insertion to the patient's vessel." no patient harm or injury.No medical intervention required.There was no delay to therapy.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one psi kit for evaluation.Signs-of-use were observed on the returned dilator.Dimensional analysis was not required as a part of this complaint investigation.Functional analysis was not required as a part of this complaint investigation.Additional testing was not required as a part of this complaint investigation.All complaints are trended across product families on a monthly basis.A device history record review was performed with no relevant findings.Additional document review was not required as a part of this complaint investigation.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.The customer report of the hub separated from the dilator was confirmed through complaint investigation of the returned sample.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.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: 19164654
• Report Number: 9680794-2024-00348
• Device Sequence Number: 20817704
• Product Code: DQY
• UDI-Device Identifier: 00801902001689
• UDI-Public: 00801902001689
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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-07024
• Device Lot Number: 14F23L0134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2023
• 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: NONE REPORTED
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 101 KG