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

Lot Number SFA00671

Device Problems Defective Device (2588); Gas/Air Leak (2946); Infusion or Flow Problem (2964); Temperature Problem (3022)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that during an atrial fibrillation (a fib) procedure, a smartfreeze cryo console was selected for use.After performing three successful ablations on the left side, they then went to the right superior pulmonary vein (rspv), and with the first freeze a low temperature error occurred (1-00001000-2 (balloon temperature too low)).The temperature reached -72 within 20 seconds.The physician may have been too deep in the vein and was not using fluoroscopy; he was going off of waveforms.The low temperature error was cleared and now waiting for balloon to thaw.During the thawing process, a refrigerant flow obstruction error (2-00000004-1 (high refrigerant flow detected)) occurred.Troubleshooting includes a combination of turning off the vacuum, rotating the cryo cable 180 degrees, reconnecting the cable, and reinitiating the vacuum.The error code could not be cleared.Additional troubleshooting includes replacing the cryo cable and reinitiating the vacuum, still the error code persisted.Then a hardware problem error message occurred (2-00100000-1 (venting line error detected)).During this time of troubleshooting, technical support was called for additional assistance.After waiting 5 minutes the vacuum was reinitiated again and the hardware error persisted.A new balloon and cryo cable were also opened during this time as a method of troubleshooting.Technical support recommended restarting the console.The console was restarted but the "hardware error" persisted upon reboot.That was when they decided to abort the cryo case and switched to radiofrequency (rf).When they unplugged the cable, a gas and liquid mix started spewing out of the port on the front of the console.A valve must have been stuck open because power cycling the console should have turned off the vacuum.No patient complications occurred.The procedure was completed with a non-boston scientific device.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.The fields d4 (unique identifier (udi)).Thus, this supplemental mdr is being filed.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

During a atrial fibrillation (a fib) procedure a smartfreeze cryo console was selected for use.After performing three successful ablations on the left side, then to the right superior pulmonary vein (rspv) within the first freeze a low temperature error occurred.The temperature reached -72 within 20 seconds.The physician must have been too deep in the vein and was not using fluoro and going off of waveforms.The low temperature error was cleared and now waiting for balloon to thaw.During the thawing process a refrigerant flow obstruction error occurred.Troubleshooting includes a combination of turning off the vacuum, rotating the cryo cable 180 degrees, reconnecting the cable, and reinitiating the vacuum.The error code could not be cleared.Additional troubleshooting includes replacing the cryo cable and reinitiating the vacuum, still the error code persisted.Then a hardware problem error message occurred.During this time of troubleshooting, technical support was called for additional assistance.After waiting 5 minutes the vacuum was reinitiated again and the hardware error persisted.A new balloon and cryo cable were also opened during this time as a method of troubleshooting.Technical support recommended restarting the console.The console was restarted but the hardware error persisted upon reboot.This is when the case was aborted.The device was replaced with a non-bsc device.The procedure was completed.Furthermore, when the gas cable was unplugged gas started spewing out of the port.A valve must have been stuck open because power cycling the console should have turned off the vacuum.No patient complications occurred.The device is not expected to return due to field service request.

• Brand Name: SMARTFREEZE
• Type of Device: 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): ARDEN HILL FACILITY; 4100 hamline avenue north; st paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18987714
• MDR Text Key: 338760002
• Report Number: 2124215-2024-18550
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 08714729992721
• UDI-Public: 08714729992721
• 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,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: SFA00671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2023
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male