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

Catalog Number	CP-07611-P
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the cardiologist performed pda closure on a baby.Sheath was inserted but not fully inserted.When procedure was completed, the sheath was stuck and coming out or inserting further almost as if the artery got stuck on the sheath.The surgeon had to come and remove the sheath and the artery was broken and he had to attach it again.The cardiologist did try two or three times pulling on the sheath to get it out, but it was completely stuck, then he called the surgeon to come and take it out.There was no physical damage/kinking to the sheath itself, it could be that the artery had a spasm and the sheath got stuck." the femoral artery required surgical repair.The patient's current condition is reported as "stable".
Event or Problem Description
It was reported "the cardiologist performed pda closure on baby.Sheath was inserted but not fully inserted.When procedure was completed, the sheath was stuck and coming out or inserting further almost as if the artery got stuck on the sheath.The surgeon had to come and remove the sheath and the artery was broken and he had to attach it again.The cardiologist did try two or three times pulling on the sheath to get it out, but it was completely stuck, then he called the surgeon to come and take it out.There was no physical damage/kinking to the sheath itself, it could be that the artery had a spasm and the sheath got stuck." the femoral artery required surgical repair.The patient's current condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CATH LAB SHEATH INTRO SET
• Common Device Name: INTRODUCER CATHETER
• 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: 22726099
• Report Number: 9680794-2025-00664
• Device Sequence Number: 21095110
• Product Code: DQY
• UDI-Device Identifier: 00801902002136
• UDI-Public: (01)00801902002136(11)240125(17)281231(10)14F24A0157(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K924607
• Number of Events Summarized: 1
• Summary Report (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): 07/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CP-07611-P
• Device Lot Number: 14F24A0157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2024
• 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