MAUDE Adverse Event Report: VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

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

Patient Problems Dyspnea (1816); Fatigue (1849); Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 09/21/2015

Event Type  Injury  

Event Description

Following a pulmonary vein isolation procedure, the patient developed pericarditis.The patient presented to the follow up visit on (b)(6) 2015 with symptoms of dyspnea and fatigue and was admitted to the hospital.A chest x-ray and ct scan revealed bilateral pleural effusions and a pericardial effusion, which was treated with a pericardiocentesis.The patient was also started on steroids and diuretics and was discharged four days later.There were no alleged performance issues with any sjm device during the ablation procedure.

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 pericarditis was procedure related.Per the ifu, pericarditis is a known risk during the use of this device.

Event Description

The patient is doing well and has fully recovered.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): VENUSA DE MEXICO S.A. DE C.V.; calle hertz 1525-6; parque industrial j. bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer (Section G): VENUSA DE MEXICO S.A. DE C.V.; calle hertz 1525-6; parque industrial j. bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5678801
• MDR Text Key: 45910811
• Report Number: 9680001-2016-00045
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P130026
• 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,Followup
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• 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
• Treatment: INQUIRY OPTIMA CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR