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 Fracture (1260); Communication or Transmission Problem (2896); Electrical Shorting (2926); Gas/Air Leak (2946)

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

Event Date 05/22/2022

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, there were air bubbles in the cable and the catheter did not show electrical signals.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle, consistent with the reported ¿air bubbles.¿ electrodes 1-4 met specifications during electrical testing, however, multiple short circuits were detected.Further investigation revealed dried saline within the connector, consistent with the observed short circuits, fluid within the tubing, and the reported electrical issue.The catheter met specifications during leak testing and the observed fluid within the tubing was unable to be replicated.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fluid within the tubing and the resulting short circuits remains 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: 14634340
• MDR Text Key: 294769168
• Report Number: 9680001-2022-00026
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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: 7526055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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