MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SUPREME¿ ELECTROPHYSIOLOGY CATHETER, HEXAPOLAR (UNIPOLAR RECORDING), 120 CM LENG; DIAGNOSTIC EP CATHETER

Model Number	401877
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A cardiac tamponade was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported tamponade could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
9680001-2018-00149, 3008452825-2018-00341, 2182269-2018-00122.Following a vt ablation procedure, a tamponade occurred.The procedure was completed with no performance issues noted and an echocardiogram immediately following the procedure was normal.The day following, the patient didn¿t feel well.An echocardiogram revealed a tamponade for which a pericardiocentesis was performed to stabilize the patient.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, HEXAPOLAR (UNIPOLAR RECORDING), 120 CM LENG
• Common Device Name: DIAGNOSTIC EP CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 7931536
• Report Number: 2182269-2018-00127
• Device Sequence Number: 13815215
• Product Code: DRF
• UDI-Device Identifier: 05414734201612
• UDI-Public: 05414734201612
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K002976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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 Expiration Date: 01/31/2021
• Device Model Number: 401877
• Device Lot Number: 6311834
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention