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

Model Number	REF 301-08
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this incidents needs further details from the user/customer.These are: - were a cuff check performed with both tracheostomy tubes before use - not reported.- which method was used to measure the cuff pressure? - not reported.- what was the measured pressure when the leakage was detected? - not reported.Furthermore, both affected tubes returned to tracoe for investigation.On both tubes a tiny little hole was detected nearly at the same place in the distal part of the cuff.After 14 days (1.Cannula) and 21 days (2.Cannula) of use the cuff of the twist tracheostomy tube leaked.There are several causes possible which all lead to the same defect of a cuff leakage.1.Sharp edged structures of the tracheostoma or trachea (cartilage) rub against the thin cuff material.It was not communicated if an initial cuff test was performed with both cannulas.But the use time of 14 and 21 days showed that the cuff was tight for a long time and some influences of use have led to a leakage.Because of missing details from use it keeps unclear which kind of influences supported the defect occurance.
Event or Problem Description
After 14 days (1.Cannula) and 21 days (2.Cannula) of use the cuff or the cuff system of the tracoe twist tracheostomy cannula leaked.On both cannulas a tiny little hole was detected at more or less the same place.T was reported that the patient was shortly desaturated and need a tube change.

• Brand Name: TRACOE TWIST TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF
• 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: 20083880
• Report Number: 8010485-2024-00028
• Device Sequence Number: 7838164
• Product Code: JOH
• UDI-Device Identifier: 04035324033010
• UDI-Public: 04035324033010
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/28/2024

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 301-08
• Device Catalogue Number: REF 301-08
• Device Lot Number: 1100005588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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: Other
• Patient Sex: Unknown