MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406840
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4, a pericardial effusion occurred requiring a pericardiocentesis and protamine.During transseptal puncture, the sheath crossed the interatrial septum without use of the needle.Due to the patient's anatomy, the transseptal puncture height was only 2.7cm, however, this was the maximal height that could be achieved.The puncture site was deemed safe by the physician, so the procedure was continued.The steerable guide catheter (sgc) and clip delivery system (cds) were inserted and placed on the valve without issues.However, while evaluating the implant, the systolic pressure went from approximately 90 to 50.A large pericardial effusion was observed behind the right ventricle (rv).The clip was deployed and pericardiocentesis was performed.The systolic pressure returned to normal, and protamine was administered.The patient left the operating room intubated and stable.The physician suspected the sheath caused the pericardial effusion during transseptal puncture or during interaction with the right atrial appendage when the transseptal system was being placed in the svc.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20588643
• Report Number: 3005334138-2024-00454
• Device Sequence Number: 6550478
• Product Code: DYB
• UDI-Device Identifier: 05414734203340
• UDI-Public: 05414734203340
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061015
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 406840
• Device Catalogue Number: 406840
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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