MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TRUFREEZE SPRAY CRYOTHERAPY SYSTEM

Model Number CC301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Low Oxygen Saturation (2477)

Event Date 05/07/2021

Event Type  Death  

Manufacturer Narrative

On follow-up with the user facility, steris endoscopy learned that the patient's medical history and comorbidities included prior treatment for esophageal cancer, airway fire, and coronary artery disease.A steris endoscopy representative was present during the procedure and stated that the user facility used the appropriate spray catheter and patient monitoring.There was no evidence of any malfunction of the trufreeze system during the procedure.A steris endoscopy review of the trufreeze system console log confirmed normal operation.The instructions for use include the following warnings and precautions: "the physician should carefully consider patient eligibility for cryospray ablation (i.E., cryosurgery and associated gas pressure), including patient presentation, medical history, comorbidities (e.G., copd, cad), and prolonged use of steroids that may reduce the patient's tissue compliance and tissue strength affecting their ability to tolerate cryospray." no additional issues have been reported.

Event Description

The user facility reported an emergency procedure for treatment of a tracheal stenosis, including the use of the trufreeze system, which is used to deliver liquid nitrogen for cryotherapy treatments.The patient was unstable with low oxygen saturation levels during removal of a mucus plug from the trachea and during dilation of the trachea with a rigid bronchoscope.The patient returned to baseline and was then treated with spray cryotherapy which was performed without incident.The bronchoscope was re-introduced and the patient again became unstable and could not be resuscitated.The physician who performed the procedure reported the event was not related to the treatment with the trufreeze system.

• Brand Name: TRUFREEZE SPRAY CRYOTHERAPY SYSTEM
• Type of Device: CRYOTHERAPY SYSTEM
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 11941320
• MDR Text Key: 254349809
• Report Number: 1528319-2021-00020
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CC301
• Device Catalogue Number: CC301
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death