MAUDE Adverse Event Report: VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number PN-004 065

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Embolism (1829); Fistula (1862); Pericardial Effusion (3271)

Event Date 01/12/2016

Event Type  Death  

Event Description

Following a pulmonary vein isolation procedure, the patient developed an atrioesophageal fistula.Following the ablation procedure, an atrioesophageal fistula with an associated pericardial effusion was revealed via a ct scan and egd.The fistula was treated with a covered stent and the patient is currently in critical condition status post embolic stroke.There were no performance issues with any sjm device during the ablation procedure.

Manufacturer Narrative

(b)(4) additional information: five sections.(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 contact forces exceeding 70 grams occurred during ablation.The tacticath quartz contact force ablation catheter instructions for use warns the user, ¿contact force in excess of 70 g may not improve the characteristics of lesion formation and may increase the risk for perforation during manipulation of the catheter.¿ 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 atrioesophageal fistula was 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 is now deceased.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM
• 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: 5455871
• MDR Text Key: 38860866
• Report Number: 9680001-2016-00023
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

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: 09/25/2017
• Device Model Number: PN-004 065
• Device Lot Number: 5277469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2015
• 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): Death; Other
• Patient Age: 28 YR