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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure, while checking the connections of the catheter it was noted that the water came into the cable of the catheter from the pump tubing.The catheter was exchanged to continue the procedure with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3.(b)(4) 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 water observed within the catheter.In addition, dried saline was noted within the connector plug, consistent with the reported contact force and electrical issues.Further testing revealed a leak at the luer/irrigation tubing junction due to a gap in the adhesive between the irrigation tube and the proximal tube inside the luer lock, allowing fluid to flow outside of the irrigation tubing and into the proximal tubing.This is consistent with the dried saline noted within the connector plug.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The gap in the adhesive between the irrigation tube and the proximal tube inside the luer lock was determined to be supplier related.

• 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: 16218602
• Report Number: 9680001-2023-00004
• Device Sequence Number: 12635567
• 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): 04/14/2023

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: 03/25/2023
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 7852128
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 04/14/2023
• 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
• Patient Sex: Unknown