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

Lot Number	0033190043
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
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 ongoing use there was a leak from the console.The site contacted tech services to notify them that the smartfreeze console was leaking.This was not during a procedure and there was no patient involvement, no injury to any other personal was reported.The issue could not be troubleshooted over the phone so a field service engineer went to the site.Damage to the hose that runs between the n2o tank and the processing plate was identified.Replacement of the hose was required.The console is not expected to be returned as it was serviced on site.
Event or Problem Description
It was reported that during ongoing use there was a leak from the console.The site contacted tech services to notify them that the smartfreeze console was leaking.This was not during a procedure and there was no patient involvement, no injury to any other personal was reported.The issue could not be troubleshooted over the phone so a field service engineer went to the site.Damage to the hose that runs between the n2o tank and the processing plate was identified.Replacement of the hose was required.The console is not expected to be returned as it was serviced on site.
Additional Manufacturer Narrative
The console was not returned to boston scientific's post marky laboratory for analysis; however, the console was serviced by a field technician.The report from that service call was analyzed and confirmed the allegation of a leak from the console.A hose connecting the n20 tank to the rest of the console was replaced due to a leak.The cause of the issue was traced to component failure due to the deficiencies of the connecting hose.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18301132
• Report Number: 2124215-2023-69833
• Device Sequence Number: 11665985
• Product Code: OAE
• UDI-Device Identifier: 08714729992721
• UDI-Public: 08714729992721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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
• Device Lot Number: 0033190043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown