MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TEMNO EVOLUTION®; BIOPSY NEEDLE

Model Number	10884450443405
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly male in the ct scan diagnostic imaging for percutaneous lymph node biopsy.No patient involvement as device was not introduced into patient.Device-related only, this patient was not affected as the device was tested first to be sure the lid/cap of the introducer would be able to be removed from the introducer as recently there have "been a few" instances whereby the introducer is deployed, and when ready to add the biopsy needle into the introducer the cap would not release and then the procedure would have to be redone (first introducer withdrawn, another kit opened and then the new introducer utilized).Our work around/temporary process is to be sure the lid is not adhered to the introducer.In this particular case, no delay in process but a second biopsy device was required and in the past each case apparently utilized more than one due to this now-revealed issue.We do not have an accurate count of previous issues but moving forward the team will not only make note but also secure the device information.
Event or Problem Description
An elderly male in the ct scan diagnostic imaging for percutaneous lymph node biopsy.No patient involvement as device was not introduced into patient.Device-related only, this patient not affected as the device was tested first to be sure the lid/cap of the introducer would be able to be removed from the introducer as recently there have "been a few" instances whereby the introducer is deployed and when ready to add the biopsy needle into the introducer the cap would not release and then the procedure would have to be redone (first introducer withdrawn, another kit opened and then the new introducer utilized).Our work around/temporary process is to be sure the lid is not adhered to the introducer.In this particular case, no delay in process but a second biopsy device was required and in the past each case apparently utilized more than one due to this now-revealed issue.We do not have an accurate count of previous issues but moving forward the team will not only make note but also secure the device information.

• Brand Name: TEMNO EVOLUTION®
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 14280116
• Report Number: 14280116
• Device Sequence Number: 11980500
• Product Code: FCG
• UDI-Device Identifier: 00884450443408
• UDI-Public: (01)00884450443408
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022
• Report Date (Section F): 04/19/2022

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: Other
• Device Model Number: 10884450443405
• Device Catalogue Number: CTT1820/B
• Device Lot Number: 12217644
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Race: White
• Date Report Sent to FDA: 04/19/2022