BOSTON SCIENTIFIC CORPORATION SMARTFREEZE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Lot Number SFA00671 |
Device Problems
Defective Device (2588); Gas/Air Leak (2946); Infusion or Flow Problem (2964); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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# response to allegations.The reported allegations in the complaint are not confirmed.The returned console was visually inspected with no abnormalities or defects.The reported error codes were attempted to be reproduced by inducing a "balloon temperature too low" error and observing if the high refrigerant flow detected and venting line error detected codes appeared.Several attempts were made and the errors were not replicated.The wiring on the process plate was examined to check for any loose or intermittent connections on the valves and flowmeter.No faults were found.10 ablations were performed, alternating between 28mm and 31 mm balloon size.No issues or abnormalities were found in the ablations and no error codes were found.After the completion of each ablation, the cryo-cable was disconnected from the console and no gas was found to be leaking out of the cryo-connector.
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Search Alerts/Recalls
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