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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pain (1994); Ulcer (2274)

Event Date 12/04/2015

Event Type  Death  

Event Description

Following a successful pulmonary vein isolation procedure (pvi), the patient experienced an esophageal ulcer.A successful pvi and right sided atrial flutter ablation was performed without issue on (b)(6) 2015 and the patient was discharged home.On (b)(6) 2015 the patient was admitted to the hospital with esophagus pain when swallowing and chest pain.An esophageal ulcer was diagnosed which was treated with iv pantoloc.The patient is stable and was discharged on (b)(6) 2015.There were no performance issues with any sjm devices.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.The cause of the reported esophageal ulcer could not be conclusively determined.Per the ifu, atrioesophageal fistula is a known risk during the use of this device.

Event Description

The patient presented to the hospital on (b)(6) 2015 and expired three days later, most likely due to complications from the esophageal ulcer.No further information is available.

• 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. (JUAREZ); 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: 5316903
• MDR Text Key: 34075622
• Report Number: 9680001-2015-00046
• 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,Followup
• Report Date: 12/10/2015

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: 07/25/2016
• Device Model Number: PN-004 075
• Device Lot Number: 4718335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2015; 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2014
• 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): Death; Required Intervention
• Patient Age: 65 YR