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

Catalog Number	CL-07045
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "no issue with sheath, just the introducer.Initial assembly and use was uneventful.Went to flush introducer again and the hub sheared off completely.Wasn't able to attach the syringe to the luer.Case completed without issue.Used another introducer from another product kit.There was no reported patient harm or consequence.".
Event or Problem Description
It was reported that: "no issue with sheath, just the introducer.Initial assembly and use was uneventful.Went to flush introducer again and the hub sheared off completely.Wasn't able to attach the syringe to the luer.Case completed without issue.Used another introducer from another product kit.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
(b)(4).The reported issue of dilator hub separation was confirmed upon investigation of the returned sample.The customer returned one unit of dilator for evaluation.No significant damage observed on the lumen aside from minor tip damages.The customer used another device to complete the case.A device history record review was done, and a relevant finding related to a previously opened capa was identified.Based on the information, the most likely root cause of the issue is design deficiency.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23713536
• Report Number: 9680794-2025-01011
• Device Sequence Number: 8982542
• Product Code: DQY
• UDI-Device Identifier: 00801902001719
• UDI-Public: (01)00801902001719(11)230914(17)280731(10)14F23H0105(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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-07045
• Device Lot Number: 14F23H0105
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown