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

Model Number PN-004 065

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

Patient Problems Chest Pain (1776); Unspecified Infection (1930); Inflammation (1932)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Following a pulmonary vein isolation procedure, the patient developed pericarditis.The patient presented to emergency room two days post-procedure with chest pain radiating to jaw and was admitted to the hospital.A blood test determined elevated troponin levels and the patient was diagnosed with pericarditis.The patient was treated with colchicine and admitted overnight.The event resolved and the patient was discharged the following day.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system were returned.Review of the log files revealed the device functioned as intended and there were no contributing anomalies.Force measurements were recorded during ablation that exceeded the recommended values per the ifu; however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event.The device history record was reviewed to ensure that each manufacturing and inspection with sjm specifications and procedures.The cause of the reported pericarditis may have been procedure related.Per the ifu, pericarditis is a known risk during the use of this device.

Event Description

There were no performance issues with any sjm device during the procedure.

• 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: 6048676
• MDR Text Key: 58179825
• Report Number: 9680001-2016-00081
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2017
• Device Model Number: PN-004 065
• Device Lot Number: 5115859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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: AGILIS NXT INTRODUCER; AMPERE GENERATOR; ENSITE VELOCITY SYSTEM; REFLEXION SPIRAL CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR