MAUDE Adverse Event Report: VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number PN-004 075

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Fistula (1862)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Following an atrial fibrillation ablation procedure, the patient developed an atrioesophageal fistula.A few days after the ablation procedure, the patient presented to the emergency room with complaints of chest pain.Imaging revealed a fistula between the esophagus and the pericardium.An esophageal prosthesis was placed and the patient was transferred to the icu on antibiotics with a cardiac assist device in place.

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 atrioesophageal fistula may have been procedure related.Per the ifu, atrioesophageal fistula is a known risk during the use of this device.

Event Description

Additional information received indicated the patient recovered from the fistula and has no further issues related to the fistula.Incidentally, a ct scan revealed a brain tumor and the patient remains hospitalized.There were no performance issues during the ablation procedure.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
• 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: 5493303
• MDR Text Key: 40120192
• Report Number: 9680001-2016-00026
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/02/2016

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: 11/25/2017
• Device Model Number: PN-004 075
• Device Lot Number: 5274974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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: 59 YR