MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE TWIST TRACHEOSTOMY CANNULA; TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE AND INSERTER

Model Number	REF 306-08-P
Medical Device Problem Codes	Complete Blockage (1094); Inflation Problem (1310)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	06/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User error - no checking of the inflation line for trapping/pinching.The defect could not be verified, as no sample or photo was provided.A theoretical investigation was conducted based on the complaint description.According to the report, the inflation line became trapped between the inner and outer cannula during insertion, preventing proper cuff inflation.Traceability of lot 1100038852 (man 2024-08-19) showed no recurrence of this issue.Production records, including the cuff inflation line (art.300080.08, lot 240423/1/2/3), revealed no deviations or anomalies.The complaint description indicates that the issue occurred during use, likely due to the inflation line being pinched during insertion.This is addressed in the ifu (chapter 5), which instructs users to check that the inflation line is not trapped between cannula components.Based on current evidence, the root cause is assessed as user error.
Event or Problem Description
1) what went wrong: during a tracheostomy procedure using the tracoe experc set (ref (b)(4) with cannula model 306-08-p, a malfunction occurred at the stage of inserting and locking the inner cannula.The connection tube (filling line) between the cuff and the pilot balloon became inadvertently trapped between the outer and inner cannulae within the locking mechanism.As a result, the cuff could not be inflated properly due to compression of the cuff tubing.Even after the connection tube was released, the inflation system did not function as expected.Higher-than-normal inflation pressures were required, and deflation/aspiration from the cuff remained incomplete.Consequently, effective patient ventilation could not be ensured - because of the reduced blocking of the cuff.2) health effect: the patient had to undergo emergency orotracheal intubation followed by a repeat tracheotomy, which was successfully completed without further complication no further health effect to the patient reported.

• Brand Name: TRACOE TWIST TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE AND INSERTER
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer (Section G): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer Contact: margarete halle ; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• MDR Report Key: 22827484
• Report Number: 8010485-2025-49228
• Device Sequence Number: 9430828
• Product Code: JOH
• UDI-Device Identifier: 04035324016884
• UDI-Public: 4035324016884
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K961449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Replace
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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 Model Number: REF 306-08-P
• Device Catalogue Number: REF 306-08-P
• Device Lot Number: 1100038852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Unknown