MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. CONCERTOTM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-5-20-HELIX
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During use, the coil disconnected from the "connector" - the user did not disconnect it, it did it on its own.

• Brand Name: CONCERTOTM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10520713
• Report Number: 10520713
• Device Sequence Number: 3155610
• Product Code: KRD
• UDI-Device Identifier: 00847536013520
• UDI-Public: (01)00847536013520(17)220610(10)A846055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/26/2020
• Report Date (Section F): 08/26/2020

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: NV-5-20-HELIX
• Device Lot Number: A846055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/26/2020