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

Patient Problem Cardiac Perforation (2513)

Event Date 09/30/2015

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.The cause of the reported perforation may have been procedure related.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

Event Description

During an atrial fibrillation ablation procedure, a small pericardial effusion occurred in the left atrium.While performing ablation with the therapy cool flex blation catheter, the patient became hypotensive and fluoroscopy revealed the catheter was out of the heart silhouette.The procedure was stopped and an echocardiogram revealed a small pericardial effusion in the left atrium.No intervention was required to resolve the effusion.The patient is in stable condition.There were no performance issues with any sjm devices.

• 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: 5188253
• MDR Text Key: 29849414
• Report Number: 2030404-2015-00079
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: A088015
• Device Lot Number: 4977279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• 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
• Treatment: REFLEXION SPIRAL CATHETER
• Patient Outcome(s): Other