MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S BLUPERC PERCUTANEOUS DILATION PROCEDURAL KIT WITH SINGLE STAGE DILATOR; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/561/080
Medical Device Problem Codes	Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Codes	Forced Expiratory Volume Decreased (2430); Low Oxygen Saturation (2477)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was no visible deformation of the cuff before the procedure.After insertion of the tracheostomy tube, oxygen saturation dropped.There was high ventilation pressure, no volume enters the patient.During re-bronchoscopy, the cannula opening was displaced by the cuff (cuff hernia).This lead to an immediate cannula change.After the cannula has been removed, there was lateral bulging of the cuff found.There was patient involvement, medical intervention required.Additional adverse effects to the patient have not been reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Device evaluation: one device was received for investigation.During visual inspection no damage or anomalies were observed with the device.The reported issue was confirmed during functional testing, when the device cuff inflated unevenly.Although a definite root cause could not be established, the reported issue was attributed to over inflation of the cuff during use.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.As no manufacturing root cause could be identified, no further actions have been assigned.

• Brand Name: BLUPERC PERCUTANEOUS DILATION PROCEDURAL KIT WITH SINGLE STAGE DILATOR
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucka 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18335350
• Report Number: 3011237704-2023-00002
• Device Sequence Number: 8406525
• Product Code: BTO
• UDI-Device Identifier: 15019517103373
• UDI-Public: (01)15019517103373(11)230807(17)260710(10)4399795
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2026
• Device Catalogue Number: 101/561/080
• Device Lot Number: 4399795
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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