MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-IRVINE) THERAPY COOL FLEX, 1304-CF-7-0.5(5) 2-L-TE4BE1EB

Model Number A088016

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Loss of consciousness (2418); Cardiac Perforation (2513)

Event Date 03/13/2014

Event Type  Injury  

Event Description

During an atrial fibrillation ablation procedure using a therapy cool flex ablation catheter, a cardiac perforation occurred.A transseptal puncture was performed and a therapy cool flex ablation catheter and non-sjm catheter were advanced into the left atrium.During geometry creation, the pt became increasingly hypotensive and lost consciousness.It was noted via fluoroscopy the cardiac silhouette was not moving as expected and an echocardiogram revealed a cardiac tamponade.A pericardiocentesis was performed, however, the active bleeding continued and the pt was transferred to surgery for repair of a perforation in the left atrial appendage.The pt was stable after surgery.There were no performance issues with any sjm device.

Manufacturer Narrative

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 mfg and inspection operation was performed and indicated complete in accordance with sjm specs and procedures.Based on the info received, the cause of the reported cardiac perforation was procedure related.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• Brand Name: THERAPY COOL FLEX, 1304-CF-7-0.5(5) 2-L-TE4BE1EB
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-IRVINE); irvine CA
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3763501
• MDR Text Key: 4418905
• Report Number: 2030404-2014-00035
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P110016/S008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A088016
• Device Lot Number: 4342613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: BRK TRANSSEPTAL NEEDLE ((B)(4)); NON-SJM LASSO CATHETER (MODEL/LOT UNK)
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 76