MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CONTACT¿ THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER, IRRIGATED 4 MM TIP THERMOCOU; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A088019

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) the results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

Event Description

At the end of the procedure, a pericardial effusion was noted.Following the procedure, the patient became hypotensive and an echocardiogram was performed which revealed a pericardial effusion.The effusion resolved with no intervention and the patient was in stable condition.There were no performance issues with any sjm devices.

• Brand Name: CONTACT¿ THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER, IRRIGATED 4 MM TIP THERMOCOU
• 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: 5526437
• MDR Text Key: 41174263
• Report Number: 2030404-2016-00011
• 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: 02/29/2016

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 Model Number: A088019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/25/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 75