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); Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The reported contact force issue was confirmed.Optical fibers 1-3 no longer met specifications for optical signal properties and no contact force was displayed when connected to the tactisys quartz unit.The device did not meet specifications during a shaft leak test and an irrigation leak test.Additionally, multiple short circuits were detected.Further microscopic investigation revealed a fracture in the blue shaft material at the most proximal location of the deflectable portion of the shaft, consistent with a fractured irrigation tubing, the failed shaft and irrigation leak tests, fluid ingress proximal to electrode 4, observed short circuits, and a loss of force data during the procedure.In addition, log file analysis indicated optical fibers 1 and 2 displayed intermittent maximum cavity distance, and contact force was lost during the procedure.Further investigation revealed a leak at the irrigation tubing and tip assembly junction due to the pi irrigation tubing detaching from the metal irrigation tubing, consistent with the failed shaft and irrigation leak tests, fluid ingress under the shaft material between electrodes 1 and 2, observed short circuits, and a loss of force data during the procedure.The cause of the detected shaft fracture remains unknown.

Event Description

This report is to advise of an event observed during analysis, confirming an irrigation leak and short circuit observed in the catheter.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10441721
• MDR Text Key: 204226596
• Report Number: 9680001-2020-00043
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990040
• UDI-Public: 07640157990040
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 08/24/2020

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: 12/25/2020
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 6765202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• 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 Age: 62 YR
• Patient Weight: 85