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 A088022

Device Problem Material Puncture/Hole (1504)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a atrial fibrillation ablation procedure, a pericardial effusion occurred.Following transseptal puncture, a contact therapy cool path duo ablation catheter was advanced into the left atrium and ablation was initiated around the ostia of the pulmonary veins.While navigating the catheter, it was noted the tip of the catheter appeared outside the anatomy of the left atrium and the patient became hypotensive.An ice catheter revealed a cardiac tamponade, for which a pericardiocentesis was performed to stabilize the patient.The patient is currently in good health.There were no performance issues with the ablation catheter.

Manufacturer Narrative

(b)(4).One contact therapy cool path duo was returned for evaluation.The results of the investigation concluded that the device met all sjm specification requirements.The device met specifications prior to release from sjm manufacturing facilities as supported by a review of the device history record.The cause of the reported pericardial effusion may have been procedure related.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• 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: 5150482
• MDR Text Key: 28304530
• Report Number: 2030404-2015-00078
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Followup
• Report Date: 09/18/2015

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: 07/31/2016
• Device Model Number: A088022
• Device Lot Number: 4211892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• 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): Required Intervention
• Patient Weight: 78