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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of an event observed during analysis confirming an irrigation leak of the catheter.
Additional Manufacturer Narrative
One 65 mm tacticath quartz contact force ablation catheter was received for evaluation.Room temperature water was cycled through the device with a cool point pump and a leak was noted at the luer/irrigation tubing junction.Microscopic inspection revealed the irrigation luer is concentric within the luer hub, however, the luer appeared to be damaged.The luer hub was visually inspected, confirming a small gap between the cured adhesive and inner irrigation tubing.Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle.The root cause of the leak at the luer/irrigation tubing junction remains unknown.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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: 13456716
• Report Number: 9680001-2022-00007
• Device Sequence Number: 14954855
• 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): 02/04/2022

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: 10/25/2022
• Device Model Number: PN-004 065
• Device Catalogue Number: PN-004065
• Device Lot Number: 7525987
• 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: 01/26/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• 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