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

Catalog Number	CL-07924
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during the procedure according to ifu, md found that dilator was broken.So md opened up the new kit to finish the procedure.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one psi sheath, a 9 fr dilator, and a lidstock for analysis.Signs of use were observed.Visual analysis revealed that the dilator hub was completely separated from the dilator body.The separation points were rough and discolored.The condition of the separation point appears consistent to that of a stress related break.No other defects or anomalies were observed.The returned dilator body was removed and reinserted through the hemostasis valve of the psi.Little to no resistance was observed as the dilator passed completely through the sheath.The dilator body was removed and the hub was inserted into the cap of the hemostasis valve.The hub was able to snap into the cap and felt secure.Performed per ifu statements, "ensure dilator hub fully snaps into sheath cap".A device history record review was performed, and no relevant findings were identified.A device history record review was performed, and no relevant findings were identified.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 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.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: during the procdeure according to ifu, md found that dilator was broken.So md opened up the new kit to finish the procedure.There was no reported patient harm or consequence.

• 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: 18453470
• Report Number: 9680794-2024-00031
• Device Sequence Number: 7023995
• 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
• 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): 12/12/2023

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 Catalogue Number: CL-07924
• Device Lot Number: 14F22D0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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