MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE VARIO TRACHEOSTOMY TUBE

Model Number	REF 471-09-P
Medical Device Problem Codes	Partial Blockage (1065); Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2026 that following proper dilation, the tracheal cannula could initially be placed without difficulty.However, after the introducer was removed, a small rubber cone (a transition element to compensate for the change in calibre between the guide wire, introducer and cannula tip) remained in the lumen of the tracheal cannula.This led to a near complete occlusion, meaning that ventilation via the newly placed tracheal cannula was not possible.The situation was recognised immediately.The cannula was removed and the airway was secured by alternative means.Subsequently, a second dilation tracheotomy set was used, with which the tracheal cannula could be inserted without complications.The patient was not at risk, as the response was prompt and appropriate.
Additional Manufacturer Narrative
According to the complaint description after the introducer was removed, a small rubber cone (a transition element to compensate for the change in calibre between the guide wire, introducer, and cannula tip) remained in the lumen of the tracheal cannula.The sample was discarded.However, based on the description the error pattern could be confirmed.Based on the complaint description the issue could be assigned to the known failure pattern concerning the silicone sleeve separation investigated within capa-000444.Tracing of the lot number revealed no recurrences of the same issue within the batch; the incoming goods inspection and production data are inconspicuous.However, no batch-related issue could be identified, and - according to the risk assessment it is still within an acceptable range.Nevertheless, the investigation within capa-000444 showed that the cause is associated with the production/bonding process, however application errors cannot be completely ruled out.

• Brand Name: TRACOE VARIO TRACHEOSTOMY TUBE
• Common Device Name: TRACOE VARIO TRACHEOSTOMY TUBE
• 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: 25730559
• Report Number: 8010485-2025-76431
• Device Sequence Number: 18802865
• Product Code: JOH
• UDI-Device Identifier: 04035324019342
• UDI-Public: 4035324019342
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203362
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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 471-09-P
• Device Catalogue Number: REF 471-09-P
• Device Lot Number: 1100047362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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: 65 YR
• Patient Sex: Male