MAUDE Adverse Event Report: STELLARTECH RESEARCH CORPORATION MAESTRO 4000 POD, 100W; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 86258

Device Problem Temperature Problem (3022)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

During an ablation procedure, a maestro 4000 pod was selected for use.It was reported that during procedure the device kept shutting off due to low temperature warnings.This happened after several ablations performed successfully.When the physician wanted to apply higher power at 40w, the generator would stop ablation right after high power was set.The starting temperatures during the errors was averaging 23 degrees.The higher flow rate from the metriq pump would result in the temperature dropping to 15 degrees rapidly.The physician could not ablate at his desired powers.The pod was pulled from under the patient drape.The physician ended the procedure before any more troubleshooting steps could be attempted.Patient complications are unknown as well as product return.This event is being reported for aborted/cancelled procedure with a patient under sedation.

Manufacturer Narrative

Premarket / 510(k) # p920047, p980003, p020025.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: MAESTRO 4000 POD, 100W
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): STELLARTECH RESEARCH CORPORATION; 560 cottonwood drive; milpitas CA 95035
• Manufacturer (Section G): STELLARTECH RESEARCH CORPORATION; 560 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17564557
• MDR Text Key: 321341742
• Report Number: 2124215-2023-43949
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729861966
• UDI-Public: 08714729861966
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 86258
• Device Catalogue Number: 86258
• Device Lot Number: 0116201017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1