MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number A-FASE-DF

Device Problem Impedance Problem (2950)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

Related manufacturing reference: 3008452825-2023-00050 and 2182269-2023-00006.During the afl procedure, while using ensite x in navx, impedance and display issues were noted which caused delays to treatment.The procedure was completed using a non-abbott catheter (blazer 8mm) and the procedure was completed with no adverse consequences to the patient.During the procedure, it was noted after 15 seconds of ablating at 30w that the impedance spiked to 532 and then to 999 ohms and that the catheter appeared distorted and turned red on the system.The following troubleshooting was done with no resolution: checking the physical connection between the grounding pads and patient's body, checking that the grounds were still plugged into the ampere generator, replacing the flexability se cable, replacing the flexability se catheter, replacing the flexability catheter, replacing the safire catheter, replacing the generator, replacing the power cable and plugging directly into the hospital grounded plug receptacle, power cycling both ampere generators, reconnecting the grounding pad cables from both generators., putting a new non-abbott grounding pad (macrolyte) in a new location, putting a new non-abbott grounding pad (macrolyte) patch in a different location, disconnecting the ampere from ensite x, replacing the system reference patch, and ending and revalidating a new study.The original ground pads ended up being used a non-abbott catheter (blazer 8mm) and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One quadripolar, bi-directional, curve d-f, flexability sensor enabled ablation catheter was received for evaluation.Electrode 1 read as an open circuit.The open circuit detected was isolated to the catheter connector, consistent with the reported impedance issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the open circuit remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 16453886
• MDR Text Key: 310360824
• Report Number: 3008452825-2023-00049
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: 05415067020062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-FASE-DF
• Device Catalogue Number: A-FASE-DF
• Device Lot Number: 8753587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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
• Treatment: FLEXABILITY¿ ABL CATHETER, SE¿, MODEL A-FASE-DF; SAFIRE¿ BI-DIRECTIONAL ABL CATHETER, MODEL 402811