MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMARTFREEZE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a cryoablation, as they started the case, everything was plugged in and waiting.The physician pulled the vacuum prepped the ballon and got access to left superior pulmonary vein (lspv), then inflated the balloon the first time with the console screen.As the balloon went to increase the size of the balloon to 31mm the team grabbed the remote, and it was vibrating.The balloon was able to increase size 31mm with the press of a button on remote.Upon ablation of the lspv, the ablation temperature reached 67 degrees and the esophageal temperature was 25 degrees, so the physician requested to come off ablation.When the orange ablation off button was pressed on the controller, there was no feedback as it was vibrating, therefore they did not think it stopped the ablation.The stop button was pressed on the console screen, which hard stopped the ablation.They unpluged the remote control, plugged it back in and the vibrating stop.The procedure was completed without any complications.The device is not expected to be returned.

• Brand Name: SMARTFREEZE
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19074033
• Report Number: 2124215-2024-21567
• Device Sequence Number: 19997943
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: 08714729992691
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown