MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F; INTRODUCER, CATHETER

Model Number	405112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for an implant procedure.An excessive bleeding occurred after placement of the introducer shealth.Compression therapy was given to resolve the event.The patient was stable.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20506112
• Report Number: 2017865-2024-67913
• Device Sequence Number: 15518412
• Product Code: DYB
• UDI-Device Identifier: 05415067040893
• UDI-Public: (01)05415067040893(10)10168412(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K894431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 405112
• Device Catalogue Number: 405112
• Device Lot Number: 10168412
• 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: 09/29/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• 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: Required Intervention
• Patient Sex: Unknown