MAUDE Adverse Event Report: AMBU A/S AMBU VIVASIGHT 2 DLT; DOUBLE-LUMEN ENDOBRONCHIAL TUBE

Model Number	412371000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure with vivasight 2 dlt the cuff malfunctions were identified shortly after intubation and prior to initiation of the surgical procedure.The tube was replaced with a second tube.The patient had to be re-intubated with a third tube to gain control the airway during the procedure.It was confirmed that there was no harm to the patient and no impact on patient outcome.Two replacements and a total of three dlt tubes are required to gain control of the airway during the operation.
Additional Manufacturer Narrative
The investigation was performed on retention samples with same manufacturing lot#10000575876.Tracheal cuff functionality was checked as per working instruction.To simulate the condition prior the intubation, the tracheal cuffs were inflated, and no leakages were observed.Further simulation was performed by over-inflating the tracheal cuffs and hold them in tight condition (to simulate the condition in the tracheal area).Then, movement was introduced to the tubes to observe for possible cuff leakage during patient movement.Based on the simulation result, we were able to see the similar failure mode as per reported failure.The cuffs leaked (damage) due to high friction between the lumen wall and over inflated cuff surfaces.The customer has not provided any information on whether a pre-check was performed prior to the procedure in accordance to the instruction for use.The instruction for use states that the user should test the cuff for integrity by completely inflating and deflating prior to use.

• Brand Name: AMBU VIVASIGHT 2 DLT
• Common Device Name: DOUBLE-LUMEN ENDOBRONCHIAL TUBE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballterup, dk 2750 ; DA 2750
• MDR Report Key: 14319551
• Report Number: 1220828-2022-00006
• Device Sequence Number: 17448358
• Product Code: CBI
• UDI-Device Identifier: 05707480145737
• UDI-Public: 05707480145737
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2024
• Device Model Number: 412371000
• Device Catalogue Number: 412371000
• Device Lot Number: 1000575876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2022
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown