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

Device Problems Fluid/Blood Leak (1250); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Electrodes 1-4 met specifications for acceptable resistance values with no open circuits detected.However, multiple short circuits were detected, consistent with the reported interference issue.In addition, fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle.Further testing revealed 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 towards the optical and electrical connectors, consistent with the fluid residue noted within the connector plug, the detected short circuits, and the reported leak issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The leak at the luer/irrigation tubing junction was determined to be supplier related.Abbott is continuing to monitor the reported issue.

Event Description

This report is to advise of a short circuit and leak found during analysis.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
• Type of Device: 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: 15541401
• MDR Text Key: 304337036
• Report Number: 9680001-2022-00047
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990040
• UDI-Public: 07640157990040
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2022
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 7526091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1