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

Model Number	NV-2-8-HELIX
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The concerto coil system coiled inside the microcatheter and failed to deploy.Another coil was then used; procedural note indicates: "coil embolization of the superior rectal artery was then performed to stasis." there were no complications.

• Brand Name: CONCERTO
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8572745
• Report Number: 8572745
• Device Sequence Number: 13951275
• Product Code: KRD
• UDI-Device Identifier: 00847536013346
• UDI-Public: (01)00847536013346(17)210821(10)A696281
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2019
• Report Date (Section F): 04/26/2019

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: NV-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: A696281
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 04/26/2019