MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO TEMNO.COAXIAL BUNDLE..18G; BIOPSY NEEDLE

Catalog Number	CT1811/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a lung biopsy procedure, the biopsy needle detached within the patient.The foreign body was successfully removed vis vascular snare device.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to the manufacturing process.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.COAXIAL BUNDLE..18G
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• MDR Report Key: 11274002
• Report Number: 3011642792-2021-00002
• Device Sequence Number: 3846003
• Product Code: FCG
• UDI-Device Identifier: 00884450444177
• UDI-Public: 884450444177
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K902319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 02/20/2024
• Device Catalogue Number: CT1811/B
• Device Lot Number: I1812073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 06/01/2021
• 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; Required Intervention