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

Catalog Number	CL-07965
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the dilator body and the hub separated during use.There was no part left in the patient.The procedure was complete and there was no injury or harm to the patient.
Event or Problem Description
It was reported that: the dilator body and the hub separated during use.There was no part left in the patient.The procedure was complete and there was no injury or harm to the patient.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one psi kit for evaluation.Signs of use were observed on the returned dilator.Visual analysis revealed that the dilator hub was completely separated from the dilator body.The separation points on the dilator body and the hub were rough and discolored.The condition of the separation point appeared consistent to that of a stress related break.No other defects or anomalies were observed.A device history record review was performed with no relevant findings.The customer report of a separated dilator hub 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.A capa was implemented to address the issue of the dilator separation.The capa investigation indicates the root cause is design related.The product from the reported lot was manufactured prior to corrective actions implemented per the capa.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: 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: 19057684
• Report Number: 9680794-2024-00308
• Device Sequence Number: 20481208
• Product Code: DQY
• UDI-Device Identifier: 00801902002075
• UDI-Public: 00801902002075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CL-07965
• Device Lot Number: 14F22D0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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.; NOT REPORTED.
• Patient Sex: Unknown