MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CORVOCET¿; INSTRUMENT, BIOPSY

Model Number	00884450476390
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) male with history of right axillary adenopathy.Procedure: catscan guided biopsy (ct/bx), lymph node right axilla.Corvocet biopsy needle came apart when firing to take a sample.No known harm to patient, another corvocet used successfully.Manufacturer response for instrument, biopsy, corvocet¿ (per site reporter), will obtain.

• Brand Name: CORVOCET¿
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 14521638
• Report Number: 14521638
• Device Sequence Number: 6551990
• Product Code: KNW
• UDI-Device Identifier: 00884450476390
• UDI-Public: (01)00884450476390(17)250110(10)12343163(01)00884450476390
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/20/2022
• Report Date (Section F): 05/20/2022

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: Health Professional
• Device Model Number: 00884450476390
• Device Catalogue Number: CORCA1815B/B
• Device Lot Number: 12343163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 91 KG
• Date Report Sent to FDA: 05/20/2022