MAUDE Adverse Event Report: VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	PN-004 065
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of an event noted during analysis which revealed exposed wires.
Additional Manufacturer Narrative
One 65 mm tacticath quartz contact force ablation catheter was received for evaluation.Investigation revealed that optical fibers 1 and 2 were fractured at the location of the bend in the distal shaft, consistent with the detected optical signal loss and the reported issue.In addition, the catheter did not meet specifications during a shaft leak test due to damage to the shaft material at the location of the aforementioned bend.No fluid ingress into the shaft was noted between electrodes 1 and 2.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend in the shaft and exposed wires remain unknown.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM
• 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: 14523511
• Report Number: 9680001-2022-00025
• Device Sequence Number: 20465589
• Product Code: OAE
• UDI-Device Identifier: 07640157990033
• UDI-Public: 07640157990033
• 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): 05/27/2022

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: 01/25/2023
• Device Model Number: PN-004 065
• Device Catalogue Number: PN-004065
• Device Lot Number: 7775186
• 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: 05/26/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown