MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMARTFREEZE; CARDIAC CRYOSURGICAL SYSTEM

Lot Number PXC00121

Device Problem Device Remains Activated (1525)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 09/12/2023

Event Type  Injury  

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 Description

During a cyro pulmonary vein isolation procedure a smartfreeze console was selected for use.During the second patient of the day the first two left side freeze went without issue.Display reported all greens for the attached peripherals to the console, including the footswitch.Upon reaching minus 60c the physician tried to stop the freeze by pressing the foot pedal.This did not work.Repressing the foot pedal again did not work, the supporting electrophysiology nurse then stopped the freeze via the remote control.The patient experienced phrenic nerve palsy in the right superior pulmonary vein.No interventions were performed.The patient was admitted to hospital beyond the standard of care.The patient's current status includes permanent phrenic paresis, diaphragm condition periodically monitored by xray.The console is not expected to be returned as it will be repaired on site.

• Brand Name: SMARTFREEZE
• Type of Device: CARDIAC CRYOSURGICAL SYSTEM
• 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: 17882783
• MDR Text Key: 325061428
• Report Number: 2124215-2023-55192
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: 08714729992691
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PXC00121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization