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

Catalog Number	CL-07924
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.This discoloration appeared consistent to that of a stress related break.A device history record review was performed, and no relevant findings were identified.A capa was implemented on 14-june-2022 to address the issue of the dilator separation for part numbers l-07900-002b, l-07924-002b, l-07965-002b, l-07980-002b, w-08903-004c, l-07800-002b, l-07824-002b, l-07835-001a, l-07845-002b, l-07865-002b, l-07880-002b, w-08803-013c, and w-08803-013d.This implementation date occurred after the manufacturing date of the dilator involved with this complaint (08-june-2022).Therefore, this complaint is within scope of the capa.The capa investigation indicates the root cause is design related.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "during the procedure according to ifu, the md the the dilator was broken.So the md opened up the new kit to finish the procedure." no patient harm or injury.No medical intervention required.The second kit was used successfully.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during the procedure according to ifu, the md the the dilator was broken.So the md opened up the new kit to finish the procedure." no patient harm or injury.No medical intervention required.The second kit was used successfully.The patient's current condition is reported as "fine".

• 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: 19350379
• Report Number: 9680794-2024-00483
• Device Sequence Number: 12615597
• Product Code: DQY
• UDI-Device Identifier: 00801902002051
• UDI-Public: 00801902002051
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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-07924
• Device Lot Number: 14F23C0188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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; NONE REPORTED
• Patient Sex: Unknown