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
Medical Device Problem Codes	Fluid/Blood Leak (1250); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional 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.Ingress testing resulted in fluid observed within the fiber cavities and within the shaft proximal to electrode 4, consistent with the failed shaft and irrigation leak tests and a loss of force data during the procedure.Further investigation revealed a break in the shaft material at the transition between the catheter shaft and electrode ring 4, consistent with fluid ingress within the catheter shaft proximal to electrode 4 and the failed shaft leak test.The pi irrigation tubing was noted to remain attached to metal irrigation tubing at the deformable body and no damage was noted to the irrigation tubing throughout the device.No tears in the shaft material under electrode ring 2 were detected, no leaks at the fiber optic seal were detected, no leaks from within the handle were detected, and no leaks were detected at the irrigation tubing transition near the deflectable portion of the catheter shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the failed irrigation leak test, the fluid ingress between electrodes 1 and 2, and the tear in the shaft material under electrode ring 4 remains unknown.There was a short circuit found between e2 and e4.When electrode ring 4 was removed to inspect for shaft damage beneath the electrode ring, it was noted that conductor wire 2 was fractured at the distal end of electrode ring 4.The short circuit between e2 and e4 was no longer detected following the removal of the electrode ring, indicating that the cause of the short circuit was the contact of the fractured conductor wire 2 with electrode ring 4.Conductor wire 2 was also noted to bulge under electrode ring 4, but it was determined that the conductor wire was not protruded or exposed under the electrode ring.The cause of the fracture in conductor wire 2 remains unknown; therefore, a product deficiency could not be confirmed.
Event or Problem Description
This report is to advise of a short circuit and fluid ingress found during analysis of the catheter.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
• Common Device Name: 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: 15707737
• Report Number: 9680001-2022-00051
• Device Sequence Number: 14735627
• Product Code: OAE
• UDI-Device Identifier: 07640157990040
• UDI-Public: 07640157990040
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/25/2022
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 7775359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown