MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TRUFREEZE PASSIVE VENTING CATHETER

Model Number	CD3-001
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the trufreeze system catheter and scope experienced ice build-up preventing flow of the gas into the patient resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
The catheter was returned for evaluation and found to be operating according to specification.The reported event was unable to be duplicated.The instructions for use (ifu 15-00133-12) give the user the following cautions when using the trufreeze catheters, "when using a scope, place the catheter through the catheter introducer and into the biopsy or working channel of the scope.Ensure catheter and scope are completely defrosted before repositioning or withdrawing catheter.Withdraw catheter in the straight position.Care should be taken to avoid kinking or fracturing the catheter during handling and insertion into the catheter introducer.Caution: if using a scope in the retroflexed position, ensure catheter and scope are completely defrosted before repositioning or withdrawing.Withdraw scope and catheter in the straight position.Caution: ensure catheter and scope are completely defrosted before repositioning or withdrawing catheter.Withdraw catheter in the straight position.Caution: care should be taken to avoid kinking or fracturing the catheter during handling and insertion into the catheter introducer." steris conducted in-service training specifically on the proper use and operation of the trufreeze passive venting catheter.A complaint review confirms the lot subject of the reported event to be isolated.No additional issues have been reported.

• Brand Name: TRUFREEZE PASSIVE VENTING CATHETER
• Common Device Name: TRUFREEZE PASSIVE VENTING CATHETER
• 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: 15905295
• Report Number: 1528319-2022-00062
• Device Sequence Number: 12286248
• Product Code: GEH
• UDI-Device Identifier: 00857068006013
• UDI-Public: 00857068006013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CD3-001
• Device Catalogue Number: CO8407030501
• Device Lot Number: 2506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown