MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO CORVOCET¿.COAXIAL BIOPSY DEVICE; INSTRUMENT, BIOPSY

Catalog Number	CORCA2020B/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges that during an image-guided biopsy procedure, the coaxial introducer detached next to the patient's spine.An interventional radiologist successfully removed the device from the patient via a cut-down technique and a pair of forceps.The patient tolerated the procedure well with no additional consequences to report.

• Brand Name: CORVOCET¿.COAXIAL BIOPSY DEVICE
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16456658
• Report Number: 3011642792-2023-00010
• Device Sequence Number: 14076853
• Product Code: KNW
• UDI-Device Identifier: 00884450477663
• UDI-Public: 884450477663
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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 Catalogue Number: CORCA2020B/B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown