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 Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the supraventricular tachycardia procedure, contact force issues which resulted in procedural delays.The catheter was exchanged with no resolution.The catheter was exchanged again and the procedure was completed with no adverse consequences to the patient.During the procedure, after connecting the catheter to the tactisys, it was noted that the contact force signal was not displayed on the screen.The tactisys was checked repeatedly and the indicator light was red.The catheter was replaced, without solving the issue.The catheter was exchanged to a third one, and the procedure was completed with no adverse consequences to the patient.
Event or Problem Description
Related manufacturing reference: 9680001-2023-00017.
Additional Manufacturer Narrative
Additional information: b5, d9, d10, g3, g6, h2, h3, h6.(b)(4) 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Optical fiber 3 no longer met specifications for optical properties and no contact force was displayed when the returned device was connected to the tactisys quartz unit.Further investigation revealed that optical fiber 3 was under-polished, consistent with the observed signal loss and with the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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: 16567301
• Report Number: 9680001-2023-00016
• Device Sequence Number: 12137004
• 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,Followup
• Report Date (Section B): 05/25/2023

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: 05/25/2023
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 7526116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER
• Patient Sex: Unknown