MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; RAPID AV CATHETER

Model Number	2000177
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during two patient procedures, the rapid av catheter broke in the channel of the scope.Following a delay, user facility personnel utilized another catheter to complete the patient procedures.No report of injury.
Additional Manufacturer Narrative
Steris requested the rapid av catheters subject of the reported event be returned for evaluation.Steris further offered in-service training on the proper use and operation for the rapid av catheters and is awaiting a response.The device history record (dhr) was reviewed for the subject lot and no abnormalities were noted.Investigation of the event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The rapid av catheters subject of the reported event were returned for evaluation.During the evaluation it was found that both catheters broke in the area of the proximal end of the device where the hub handle would meet the console during the procedure.This lines up with the approximate location of the biopsy port relative to the catheter during the procedure.The evaluation confirms what the user facility observed when the catheters broke at the biopsy port during the procedures.It was further noted that one of the spring introducers was severely damaged.It appears that it was stretched and permanently deformed at some point during the procedure.The catheters and the spring introducer likely kinked and broke due to tension at the biopsy port.The instructions for use states, "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 offered in-service training on the proper use and operation for the rapid av catheters; however, the user facility declined.A complaint review was performed and confirmed this event to be isolated for the subject lot.No additional issues have been reported.

• Brand Name: TRUFREEZE
• Common Device Name: RAPID AV CATHETER
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20099833
• Report Number: 1528319-2024-00070
• Device Sequence Number: 7571472
• Product Code: GEH
• UDI-Device Identifier: 00724995199227
• UDI-Public: (01)00724995199227(11)240401(17)260401(10)4501
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 08/29/2024

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 Expiration Date: 04/01/2026
• Device Model Number: 2000177
• Device Catalogue Number: 2000177
• Device Lot Number: (10)4501
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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