MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMART ABLATE RF GENERATOR; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number M490002

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)

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

Event Date 02/04/2021

Event Type  Injury  

Event Description

Prior to atrial ablation the smart ablate rf generator displayed a list of errors.Several subsequent reboots of the generator did not pass the self-test and would immediately display the lists of errors.After multiple times (>5) rebooting, the generator passed the self-test and began operating in normal mode, but again started experiencing issues and reverted to the error list again.The clinical rep called the company's technical services department, who determined the mother board (main board) inside the ablation generator was malfunctioning based on the error numbers displayed on the generator screen.After this determination, the procedure was cancelled.Fda safety report id # (b)(4).

• Brand Name: SMART ABLATE RF GENERATOR
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; irvine CA
• MDR Report Key: 11307326
• MDR Text Key: 231584432
• Report Number: MW5099316
• Device Sequence Number: 1
• Product Code: OAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2021

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 Model Number: M490002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR