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 Problem Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.The device met specifications for temperature testing and optical signal properties.Electrical insulation between conductor wires 1-4 and the thermocouple wires was also tested while the catheter was deflected and un-deflected.Short circuits were detected between electrode 1 and electrode 2, electrode 1 and electrode 3, electrode 2 and electrode 3, and electrode 2 and electrode 4.Electrode rings 2-4 were subsequently dissected for further inspection.No breaks in the shaft were noted under electrode rings 2 and 3 but there was a break in the shaft at electrode 4.The 19-pin redel connector was disassembled.Evidence of dried saline was noted within the connector, consistent with the observed short circuits.The catheter shaft was cut proximal to the deflectable section and the tip was removed from the distal shaft.The pi irrigation tubing was found to remain attached to the metal irrigation tubing at the deformable body.The pi irrigation tubing was inspected, and it was noted that the adhesive went all the way around the inside of the tubing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the tear in the shaft material at electrode ring 4 and the resulting short circuits remains unknown.

Event Description

This report is to advise of an event observed during analysis confirming a short circuit in 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: 10756707
• MDR Text Key: 217726977
• Report Number: 9680001-2020-00056
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990040
• UDI-Public: 07640157990040
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

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: 06/25/2021
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004075
• Device Lot Number: 6965046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• 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
• Patient Age: 50 YR
• Patient Weight: 75