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

Model Number	CO8407030501
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their aire passive venting catheter was not spraying evenly resulting in a 10-minute procedure delay.No report of injury.
Additional Manufacturer Narrative
The device was returned to steris endoscopy for evaluation.A follow-up report will be submitted once the evaluation has been completed.
Additional Manufacturer Narrative
The returned catheter was evaluated by steris engineering and confirmed there was intermittent flow.Upon removal of the handle hub, it was found that the catheter had broken into two pieces.The user facility has not responded to requests for additional information or in-service training offers from steris.The exact cause of the damage to the catheter and when the damage occurred could not be determined.The instructions for use 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." no additional issues have been reported.

• Brand Name: AIRE PASSIVE VENTING CATHETER
• Common Device Name: 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: 18712606
• Report Number: 1528319-2024-00010
• Device Sequence Number: 7186411
• Product Code: GEH
• UDI-Device Identifier: 00724995199289
• UDI-Public: 00724995199289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: CO8407030501
• Device Catalogue Number: CO8407030501
• Device Lot Number: 2518
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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