MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS TEMNO EVOLUTION®; BIOPSY NEEDLE KIT

Catalog Number	CTT2015/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	05/03/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the patient remained hemodynamically stable during a biopsy procedure.Post-biopsy procedure the patient presented with air emboli symptoms.Medical intervention was necessary to prevent permanent impairment.Supportive therapy consisting of supplemental oxygen administration, intravascular volume expansion, and blood pressure support was attempted.The patient was treated in a hyperbaric chamber in an attempt to better manage their condition however this was not successful.The patient had experienced sustained seizures after the incident as well and all attempts to reduce procedure sedation were unsuccessful.Eventually, the patient succumbed to the effects of the incident and died.No additional information available.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: TEMNO EVOLUTION®
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 19306714
• Report Number: 3011642792-2024-00025
• Device Sequence Number: 12600534
• Product Code: FCG
• UDI-Device Identifier: 00884450443422
• UDI-Public: 00884450443422
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K024120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CTT2015/B
• Device Lot Number: I2549253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 05/18/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2022
• 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: Required Intervention; Death; Life Threatening; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male