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 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.The device did not meet specifications during a shaft leak test and an irrigation leak test.Further investigation revealed the shaft material had been fractured at the distal edge of electrode ring 4, consistent with the failed shaft and irrigation leak tests, fluid ingress proximal to electrode ring 4, optical signal interruption in fibers 1-3, and a loss of force data during the procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damaged shaft material, shaft leak, and fractured and exposed conductor wire was unable to be determined and remains unknown.

Event Description

This report is to advise of an event observed during analysis confirming a shaft leak.

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.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.Further investigation revealed that optical fibers 1-3 were under-polished, resulting in the obstruction of the optical fiber core, consistent with the observed signal loss and with the reported event.In addition, an adhesive-like substance was confirmed in the optical fiber cavity of fibers 1-3.

• 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: 12031458
• MDR Text Key: 257132453
• Report Number: 9680001-2021-00040
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 7300931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1