MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number PN-004 075

Device Problem Difficult To Position (1467)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/09/2015

Event Type  Injury  

Event Description

During an atrial fibrillation ablation using a tacticath quartz ablation catheter, a cardiac perforation occurred.During geometry creation in the left atrium with an inquiry optima ep catheter and a tacticath quartz ablation catheter, transseptal access of the inquiry optima ep catheter was lost.Re-access into the left atrium was attempted with the aid of the ablation catheter; however, this attempt was unsuccessful.Transseptal puncture was then completed again with the brk-1 transseptal needle without difficulty.Upon isolation of the left pulmonary veins, the patient became hypotensive.Intracardiac echo revealed a pericardial effusion and a pericardiocentesis was performed which stabilized the patient.The procedure continued and a right atrial cavotricuspid isthmus ablation line was completed with a non sjm catheter and the patient remained stable.There were no performance issues noted with any sjm device used.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Functional analysis of the returned device included, visual, electrical, temperature, and optical testing which all met sjm specifications.Review of the log files revealed the device functioned as intended and there were no contributing anomalies.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record and the analysis performed.The cause of the cardiac perforation was unable to be confirmed and remains unknown.Per the ifu, cardiac perforation is a known risk with the use of this device.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4667757
• MDR Text Key: 16558483
• Report Number: 3005334138-2015-00025
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2016
• Device Model Number: PN-004 075
• Device Lot Number: 4754949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK-1 TRANSSEPTAL NEEDLE; AMPERE GENERATOR; SWARTZ BRAIDED TRANSEPTAL INTRODUCER X 2; INQUIRY OPTIMA EP CATHETER; LIVEWIRE DUO DECA (REPROCESSED)
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR