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

Model Number PN-004 075

Device Problems Fluid/Blood Leak (1250); Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

During an atrial fibrillation radiofrequency ablation procedure, the catheter could be connected, catheter parameters are lost during the ablation process and pressure parameters did not display as expected.After cleaning, the pressure parameters were abnormal again, until they were completely lost.It was then noted that here was liquid backflow in the catheter connection the catheter was replaced and the procedure was completed with no consequences to the patient.

Manufacturer Narrative

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.The log file analysis concluded that the tacticath catheter performed as intended.The optical fibers met specifications, the recorded temperatures indicated cooling during rf ablation, and contact force measurements were displayed throughout the duration of the log files.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported issue remains unknown.

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.A bend was noted in the distal shaft of the returned device between electrodes 3 and 4, and electrode ring 3 was dented and slightly distally displaced.Further investigation revealed conductor wire 3 was noted to be fractured at the proximal edge of electrode ring 3, with conductor wire 3 protruding out of the shaft material.This fracture is consistent with the displaced electrode ring 3.The cause of the bend in the catheter shaft and the displacement of electrode ring 3 remains unknown.In addition, the device did not meet specifications during a shaft leak test due to a break in the shaft material under electrode ring 3 at the location where conductor wire 3 was fractured and protruding.Fluid ingress was noted within the distal shaft proximal to electrode ring 3, but no ingress was noted between electrodes 1 and 2.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the leak and fracture remain unknown.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14193818
• MDR Text Key: 290177916
• Report Number: 9680001-2022-00016
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990040
• UDI-Public: 07640157990040
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 7526047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 05/31/2022; 09/14/2022
• Supplement Dates FDA Received: 06/01/2022; 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2020
• 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