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 Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Contact force was displayed when the catheter was connected to the tactisys quartz unit.Functional testing revealed the catheter did not pass an irrigation test.The irrigation leak was caused by inadequate adhesive bonding between the irrigation tubing and end of deformable body at the distal tip which led to detached irrigation flow during use.This is consistent with fluid ingress and a loss of force data during the procedure.

Event Description

This report is to advise of an event observed during analysis confirming an irrigation leak of the catheter.

Manufacturer Narrative

Correction: h1.Additional information: g4.

• 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
• MDR Report Key: 8459014
• MDR Text Key: 140133019
• Report Number: 9680001-2019-00051
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990040
• UDI-Public: 07640157990040
• Combination Product (y/n): N
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2020
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 6612479
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1