MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(AF-IRVINE) THERAPY¿ COOL FLEX¿ ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A088015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported pericardial effusion may have been procedure related.Per the ifu, vascular perforation is a known inherent risk of any electrode placement.

Event Description

During an atrial tachycardia ablation procedure, a pericardial effusion occurred.During left atrial mapping with a therapy cool flex ablation catheter, the patient became hypotensive and an echocardiogram revealed a pericardial effusion originating from the left atrial appendage.The patient remained stable but a pericardiocentesis was performed to treat the effusion.There were no performance issues with any sjm device.

• Brand Name: THERAPY¿ COOL FLEX¿ ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(AF-IRVINE); 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5335570
• MDR Text Key: 34687587
• Report Number: 2030404-2015-00089
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: A088015
• Device Lot Number: 5009201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention