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 Problems Failure to Reset (1532); Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is in the process of being analyzed.When our investigation has been completed a follow-up report will be submitted.(b)(4).

Event Description

During an ablation procedure, a cardiac tamponade occurred in the left atrium.While in the left atrium, the tacticath contact force readings fluctuated and the baseline could not be reset.After the tacticath was moved from the ridge area to the right sided veins, a cardiac tamponade was noted in the left atrium, which was confirmed by ultrasound.A pericardiocentesis was performed which stabilized the patient.

Manufacturer Narrative

One tacticath quartz contact force ablation catheter was received for evaluation.The catheter displayed acceptable optical signals when connected to the tactisys quartz unit; however, during functional testing the catheter did not pass a shaft leak test.Microscopic inspection at the transition between the catheter shaft and the proximal edge of the distal tip revealed part of the adhesive was no longer adhered.It is unlikely that this finding contributed to the reported event.Review of the device history record revealed the device met specifications prior to leaving sjm manufacturing facilities.The cause of the reported cardiac perforation remains unknown.Per the ifu, cardiac perforation is a known risk with 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: 6229508
• MDR Text Key: 64078311
• Report Number: 9680001-2017-00002
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2018
• Device Model Number: PN-004 075
• Device Lot Number: 5454334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2016
• 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: ADVISOR CATHETER; BOSTON SCIENTIFIC DECA DYNAMIC CS CATHETER; BOSTON SCIENTIFIC FIXED CATHETER; ENSITE PRECISION SOFTWARE; TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER; TACTISYS QUARTZ ABLATION SYSTEM
• Patient Outcome(s): Required Intervention