MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F; Introducer, catheter

Model Number	405108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient presented for an implant procedure.The day after the procedure, the patient passed away.There is no known allegation from a health care professional that suggests that the death was device related.The cause of death was unknown.No additional information was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21748600
• Report Number: 2017865-2025-38989
• Device Sequence Number: 9414303
• Product Code: DYB
• UDI-Device Identifier: 05415067040879
• UDI-Public: (01)05415067040879(10)10526166(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K894431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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 Model Number: 405108
• Device Catalogue Number: 405108
• Device Lot Number: 10526166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown