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-004 075

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Diaphoresis (2452); Pericardial Effusion (3271)

Event Date 01/11/2016

Event Type  Injury  

Event Description

(b)(4).Following a cardiac ablation procedure, a pericardial effusion occurred.Approximately 4.5 hours after completion of the ablation procedure using a tacticath quartz ablation catheter, the patient complained of chest pain, dyspnea, and diaphoresis.An echocardiogram and ct were performed, revealing a circumferential pericardial effusion over the lateral and free wall of the right ventricle.The patient was transferred to the ccu and a pericardiocentesis was performed, which stabilized the patient.A follow up echocardiogram revealed no pericardial effusion; the pericardial drain was removed two days post-procedure, and the patient was discharged from the hospital on coagulants five days later.There were no performance issues with any sjm device.

Manufacturer Narrative

(b)(4) 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• 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: 5453057
• MDR Text Key: 38757908
• Report Number: 9680001-2016-00009
• 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: 01/27/2016

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: 01/25/2017
• Device Model Number: PN-004 075
• Device Lot Number: 49544447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR