MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. TEMNO ELITE¿.VALVED COAXIAL BUNDLE; INSTRUMENT, BIOPSY DEVICE

Catalog Number	TEVC2010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device is not expected to return for evaluation.The device has been discarded by the account.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were identified.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges that during a lung biopsy, an outpatient experienced an air embolism.The patient was intubated and transferred to icu for further observation.

• Brand Name: TEMNO ELITE¿.VALVED COAXIAL BUNDLE
• Common Device Name: INSTRUMENT, BIOPSY DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19943156
• Report Number: 1721504-2024-00050
• Device Sequence Number: 7319477
• Product Code: KNW
• UDI-Device Identifier: 00884450397756
• UDI-Public: 884450397756
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2024

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: TEVC2010
• Device Lot Number: H2800412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown