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

Model Number PN-004 075

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Related manufacturer reference 3008452825-2016-00016, 3005188751-2016-00005, 3005188751-2016-00006, 3005334138-2016-00008.During a left-side atrial tachycardia ablation procedure, a pericardial effusion occurred.A livewire duo-decapolar catheter was placed in the coronary sinus and an unknown sjm jsn catheter was placed in right ventricle.A transseptal puncture was performed with a brk transseptal needle through a fast cath swartz introducer.At this time, a small pericardial effusion was noted; however, no intervention was performed and it was decided to monitor the effusion throughout the procedure.A tacticath quartz ablation catheter was advanced into the left atrium to begin mapping the atrial tachycardia but was then replaced with a reflexion spiral catheter.Once geometry was completed the patient became increasingly hypotensive and the patient was prepped for a pericardiocentesis due to the pericardial effusion.A cardioversion was performed prior to the pericardiocentesis; however, the patient became asystolic and cpr was administered.The patient rhythm exhibited pulseless electrical activity at one point and the pericardiocentesis was eventually successful, which stabilized the patient.The patient was awake and alert the next day.There were no performance issues with any sjm device during the procedure.

Manufacturer Narrative

(b)(4).Functional analysis of the returned device included, visual, electrical, temperature, irrigation and optical testing which all met sjm specifications.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 met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record and the analysis performed.The cause of the reported pericardial effusion was unable to be confirmed and 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. (JUAREZ); calle hertz 1525-6; parque industrial j. bermudez; ciudad juarez, chihuahua MN 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: 5439351
• MDR Text Key: 38288307
• Report Number: 9680001-2016-00014
• 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: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2017
• Device Model Number: PN-004 075
• Device Lot Number: 5135455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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