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

Model Number	00884450316634
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged female with history of diabetes, epilepsy, proteinuria and chronic kidney disease.Procedure in interventional radiology ct- biopsy renal core.Upon opening the biopsy needle, dr.Saw that the very end tip of the biopsy needle was bent outward.He attempted to check this needle for attempted use but opened a 2nd needle for use.No harm done to patient.

• 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: 10178374
• Report Number: 10178374
• Device Sequence Number: 908632
• Product Code: KNW
• UDI-Device Identifier: 00884450316634
• UDI-Public: (01)00884450316634(17)230106(10)H1749802
• 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): 06/11/2020
• Report Date (Section F): 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450316634
• Device Catalogue Number: CORCA1815B/A
• Device Lot Number: H1749802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/11/2020