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 Consequences Or Impact To Patient (2199)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Optical fibers 1-3 met specifications for optical properties and contact force was displayed when the returned device was connected to the tactisys unit, with no error messages noted.The device met specifications during temperature testing.However, multiple short circuits were detected during electrical testing.Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle and the device did not meet specifications during an irrigation leak test.In addition, dried saline was noted within the connector plug, consistent with the short circuits detected.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 dried saline noted within connector plug and the failed irrigation leak test.

Event Description

This report is to advise of an event observed during analysis confirming an irrigation leak and short circuit of the catheter.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10282226
• MDR Text Key: 199261658
• Report Number: 9680001-2020-00038
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990040
• UDI-Public: 07640157990040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 6965129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/16/2020
• Date Device Manufactured: 09/24/2019
• 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