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 Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Visual Impairment (2138)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Related manufacturer reference 9680001-2016-00022, 3005188751-2016-00009, 3005334138-2016-00010, 2030404-2016-00007, 3008452825-2016-00023, 3005188751-2016-00010.Following an atrial fibrillation ablation procedure, a cerebrovascular accident occurred.During the procedure a rise in impedance occurred and the ablation catheter was exchanged for another of the same model to complete the procedure.Following the procedure, the patient experienced double vision and an mri was performed, which revealed a cerebrovascular accident.No intervention was required to treat the patient and the patient was stable with double vision and issues with equilibrium at the time of this report.The physician was uncertain as to the cause of the cerebrovascular accident.

Manufacturer Narrative

(b)(4).Additional information: evaluation codes.One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.The results of the investigation concluded that electrical and insulation testing for electrode 1 met specifications while the catheter was undeflected, deflected, and manipulated.The cause of the reported impedance issue remains unknown.In addition, the catheter displayed acceptable optical signals when connected to the tactisys quartz unit.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.The cause of the reported cerebrovascular accident cannot be conclusively determined.Per the ifu, cerebrovascular accident is a known risk during the use of this device.

• 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: 5454541
• MDR Text Key: 38817518
• Report Number: 9680001-2016-00020
• 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: 02/03/2016

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: 10/25/2017
• Device Model Number: PN-004 075
• Device Lot Number: 5202972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR