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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Report received from china medical device ae reporting system states: on (b)(6) 2025, the patient accepted pacemaker implantation for type ii av block degree ii, preoperative preparation was normal.During the operation, bleeding was high after placement of the peel-away introducer and compromised the procedure.The physician gave cotton ball compression to reduce bleeding.The physician thought the peel-away introducer had poor seal.
Additional Manufacturer Narrative
Note: this report was created based on information received from an adverse incident report submitted by (b)(6) hospital directly to china medical device ae reporting system (http://maers.Adrs.Org.Cn).
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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23791585
• Report Number: 2017865-2025-1007205
• Device Sequence Number: 5522125
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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