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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/05/2021

Event Type  malfunction  

Event Description

This event is being reported due to a leak in the catheter noted during analysis.

Manufacturer Narrative

One 65 mm tacticath quartz contact force ablation catheter was received for evaluation.The device met specifications during an irrigation leak test but did not meet specifications during a shaft leak test.Further testing revealed evidence of fluid ingress proximal to electrode 4 due to a tear in the shaft material at the proximal edge of electrode ring 4, consistent with the failed shaft leak test.The catheter shaft had been bent at electrode 4, consistent with the tear in the shaft material.Fluid ingress was also noted between electrodes 1 and 2, consistent with the reported contact force issue.However, the pi irrigation tubing was noted to remain attached to metal irrigation tubing at the deformable body and no damage was noted to the irrigation tubing at the distal end of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fluid ingress between electrodes 1 and 2 remains unknown.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM
• 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
• MDR Report Key: 13720354
• MDR Text Key: 288659759
• Report Number: 9680001-2022-00010
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990033
• UDI-Public: 07640157990033
• 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: 03/10/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: PN-004 065
• Device Catalogue Number: PN-004065
• Device Lot Number: 7525988
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/10/2022
• 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