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 Electrical Shorting (2926)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Electrode 3 read as an open circuit during electrical testing and a short circuit was detected between electrode 1 and electrode 3, consistent with the reported event.Dissection revealed that conductor wire 3 was fractured within the deflectable portion of the catheter shaft, consistent with the open circuit detected.The fractured end of conductor wire 3 was noted to contact the catheter spine, consistent with the short circuit detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wire remains unknown.

Event Description

This report is to advise of a short circuit noted during analysis.

• 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: 16598809
• MDR Text Key: 312283283
• Report Number: 9680001-2023-00018
• 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
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2023
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 7852138
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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