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

Lot Number	SFA00667
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure to treat atrial fibrillation with a smartfreeze console, error 1 - 00000020-2: outer balloon pressure is too high was displayed during case.The issue was identified during inflation and was observed in ripv and rspv.Troubleshooting performed included disconnecting and reconnecting the cryo cable, replacement of cryo cable and balloon, and a power cycle.No defects were observed in the catheter.The console was replaced due to a faulty sv9 valve.No patient complications occurred.The physician decided to abort the cryo ablation and proceed with radiofrequency (rf).This event is being reported due to procedure cancellation while the patient was under general sedation.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory this device was analyzed.The returned sv9 was connected to test console and outer balloon pressure rapidly increased resulting in error 1-00000020-2 the outer balloon pressure is too high during the inflation state.The sv9 was examined, and a white crystalline debris was found on the plunger.This crystalline debris contained elevated levels of sulfur, butyl zimate and zinc stearate.The white fiber was found to be consistent to teflon tape.This failure is addressed under capa-00007933: smartfreeze console sv9 solenoid valve obp failure.
Event or Problem Description
It was reported that during an ablation procedure to treat atrial fibrillation with a smartfreeze console, error 1 - 00000020-2: outer balloon pressure is too high was displayed during case.The issue was identified during inflation and was observed in ripv and rspv.Troubleshooting performed included disconnecting and reconnecting the cryo cable, replacement of cryo cable and balloon, and a power cycle.No defects were observed in the catheter.The console was replaced due to a faulty sv9 valve.No patient complications occurred.The physician decided to abort the cryo ablation and proceed with radiofrequency (rf).This event is being reported due to procedure cancellation while the patient was under general sedation.

• 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: 18916834
• Report Number: 2124215-2024-15941
• Device Sequence Number: 17865598
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: 08714729992691
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 05/23/2024

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: SFA00667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown