MAUDE Adverse Event Report: ST JUDE MEDICAL INC. (AF-IRVINE COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB

Model Number 83563

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Loss of consciousness (2418)

Event Date 02/14/2014

Event Type  Injury  

Event Description

During a right ventricular outflow tract (rvot) ablation procedure using a therapy cool path duo ablation catheter, a cardiac tamponade occurred.A non-sjm screw lead was placed in the right ventricle.A therapy screw lead was placed in the right ventricle.A therapy cool path duo ablation catheter was advanced to the rvot; however, placement was difficult due to complicated pt anatomy.During ablation, the patient became hypotensive and lost consciousness due to a cardiac tamponade.A pericardiocentesis was performed, which stabilized the patient.The patient was sent to the cardiac care unit and was doing well.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.A review of the device history record was not possible since the lot number was unavailable.Based on the info received, the cause of the reported cardiac tamponade was procedure related.Per the ifu, vascular perforation is a known inherent risk of electrode placement.

• Brand Name: COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB
• Manufacturer (Section D): ST JUDE MEDICAL INC. (AF-IRVINE; 2382 morse ave.; irvine CA 92614
• Manufacturer (Section G): IRVINE BIOMEDICAL, INC.; 2382 morse ave.; irvine CA 92614
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st paul, MN 55117 ; 6517564470
• MDR Report Key: 3701007
• MDR Text Key: 17275055
• Report Number: 2030404-2014-00025
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P110016
• 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: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 83563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2014
• 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: MEDTRONIC SCREW LEAD (6416-200CM LOT UNK; 6F TERUMO SHORT INTRODUCER MODEL/LOT UNK; 8F TERUMO SHORT INTRODUCER MODEL/LOT UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 76