MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported death remains unknown.

Event Description

Related manufacturing ref: 3008452825-2024-00003, 3008452825-2024-00004.3008452825-2024-00005, 3008452825-2024-00006, 3008452825-2024-00007.Abbott ep eu mdr feasibility report: ablation catheters.Background: a retrospective observational study was conducted to assess the long-term safety and effectiveness outcomes on abbott¿s ablation catheters, specifically therapy and therapy dual 8, tacticath se, flexability, and flexability se, using data from the pinc aitm healthcare database (phd), a comprehensive u.S hospital chargemaster database.In the study, device information was extracted using sting search from the chargemaster data in phd, incidence rates for safety endpoints up to 12 months post- procedure were calculated.The safety endpoints included cardiac perforation/tamponade, major bleeding, stroke/transient ischemic attack (tia), and heart block with cardiac rhythm management.Additionally, effectiveness in treating arrhythmias including af, svt, and vt were evaluated by calculating the incidence of recurrence, which was captured by primary diagnosis codes of the arrhythmia in the data.The following complications occurred: six events of death within 7 days (of those only five was associated with the tacticath se ablation catheter).

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18512309
• MDR Text Key: 332867303
• Report Number: 3008452825-2024-00008
• Device Sequence Number: 1
• Product Code: OAE
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death