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)
Date of Event	01/21/2022
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.The device did not meet specifications during a shaft leak test and an irrigation leak test.Further investigation revealed the shaft had been bent at the distal edge of electrode ring 4, and fluid ingress was noted proximal to electrode ring 3.Conductor wire 3 was determined to have fractured at the location of the bend, allowing fluid ingress into the shaft under electrode ring 4.In addition, the irrigation tubing was noted to be damaged at the location of the bend in the shaft, consistent with the observed fluid ingress, the failed shaft leak test, the failed irrigation leak test.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 resulting fluid ingress, failed leak tests, and shaft damage remains 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: 14492791
• Report Number: 9680001-2022-00022
• Device Sequence Number: 14957343
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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: 7775182
• 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: 05/12/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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