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

Catalog Number	ACT2211
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a biopsy procedure, the tip of a biopsy needle detached within the patient's tumor.The initial two previous passes of the biopsy needle were successful.On the third pass, the clinician noted that it was much stiffer and after firing the tip detached within the tumor.An additional biopsy device was utilized to obtain several more specimens from the patient without incidence.The patient was discharged to home with the detached tip embedded within the patient's the tumor.No complications have been experienced by the patient.It was noted that the detached tip will be retrieved when the tumor is surgically removed.
Additional Manufacturer Narrative
The suspect device is not returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.Device history record was reviewed, and no exception documents were found.Should the catheter be returned later, the investigation will be re-opened.

• Brand Name: TEMNO NEEDLE BIOPSY
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,
• MDR Report Key: 9857535
• Report Number: 1721504-2020-00017
• Device Sequence Number: 3307923
• Product Code: FCG
• UDI-Device Identifier: 00884450444085
• UDI-Public: 00884450444085
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K024120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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 Expiration Date: 08/12/2023
• Device Catalogue Number: ACT2211
• Device Lot Number: 0001261270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other