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

Model Number A088015

Device Problems Leak/Splash (1354); Impedance Problem (2950); Temperature Problem (3022); Noise, Audible (3273)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 05/14/2015

Event Type  Injury  

Event Description

During a cardiac ablation procedure, a cardiac perforation and subsequent stroke occurred.During the ablation performed with a therapy cool flex ablation catheter, noise, impedance, and high temperature issues were noted approximately two hours into the procedure.The generator stopped ablation appropriately due to the temperature issues.A steam pop occurred during ablation in the right atrium and inspection of the catheter revealed saline leakage from the handle; therefore, the catheter was replaced and the procedure continued successfully with no adverse effect on the patient.Approximately 8 hours later, the patient complained of pain and an echocardiogram revealed a cardiac tamponade, for which a pericardiocentesis was performed.An echocardiogram was negative for thrombus.The patient then developed transient stroke symptoms, which were treated with anticoagulation.The patient was then stabilized.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).One therapy cool flex ablation catheter was returned for evaluation.The results of the investigation concluded that the catheter no longer met specifications for electrical testing and flow testing simulation due to a leak found in the catheter handle.The leak was due to a fracture in the fluid lumen in the catheter handle.Saline leaked from the fracture into the catheter connector, creating short circuits, which is consistent with the noise, high temperature, and high impedance observed.The fractured fluid lumen is consistent with damage during use.The device met specifications prior to release from sjm manufacturing facilities as supported by the device history record.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• 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.; 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: 4836015
• MDR Text Key: 16993791
• Report Number: 2030404-2015-00049
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: A088015
• Device Lot Number: 4910024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR