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

Model Number	REF 306-08
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
1) the incident occurred on (b)(6) 2025 at app.06:30, the patient developed signs of respiratory distress.Multiple suction attempts were performed using both oral and closed suction via the tracheostomy tube, but these did not relieve the obstruction.The inner cannula was checked and appeared clear.When another deep closed suction attempt was made, it became apparent that there was a possible blockage located deeper than the inner cannula.Fio2 was increased to 100% and the ventilator was disconnected to allow the use of a tendertip open suction catheter.This intervention provided partial relief after several passes (approximately five attempts).Due to the ongoing difficulty and suspicion of a deeper blockage, the clinical team performed a bronchoscopy.This revealed what appeared to be plastic material.Obstructing the airway, leaving only a small residual lumen.The device's cuff had slipped down the shaft.Of the tube, partially blocking the patient's airway.Although the cuff remained attached, its displacement beyond the distal end of the tube caused the obstruction.The decision was made to immediately replace the tracheostomy tube.2)following tube exchange, suctioning was possible, oxygen saturation improved, and the patient's condition stabilized.
Additional Manufacturer Narrative
According to the complaint description and clinical findings, the tracheostomy tube cuff had slipped.Down the shaft of the tube and was partially blocking the cannula during use, resulting in airway obstruction and respiratory distress.As the lot number was not available and the product was not returned, no batch record review or physical investigation could be performed.Based on the available information, the complaint may be related.To the known cuff gluing issue (processed in a capa, without the lot number the tracing before or after the capa measure is not possible), although this cannot be conclusively confirmed.Without further evidence, the root cause cannot be definitively established.

• Brand Name: TRACOE TWIST TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE
• 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: 22960636
• Report Number: 8010485-2025-52408
• Device Sequence Number: 9636422
• Product Code: JOH
• UDI-Device Identifier: 04035324015160
• UDI-Public: 4035324015160
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Replace
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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
• Device Catalogue Number: REF 306-08
• Device Lot Number: N.A.
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown