MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO CORVOCET¿.COAXIAL BUNDLE; BIOPSY NEEDLE

Catalog Number	CORCA1815B/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
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 biopsy procedure, the tip of the biopsy needle became stuck in the patient.When the clinician tried to remove the device, the needle detached within the patient.The clinician was unsuccessful in attempts to remove the foreign body from the patient.The patient was referred to orthopedic trauma team for interventional surgery for foreign body removal.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it 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: CORVOCET¿.COAXIAL BUNDLE
• Common Device Name: BIOPSY NEEDLE
• 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 ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12174196
• Report Number: 3011642792-2021-00016
• Device Sequence Number: 13693440
• Product Code: KNW
• UDI-Device Identifier: 00884450476390
• UDI-Public: 884450476390
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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 Catalogue Number: CORCA1815B/B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown