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

Model Number	NV-3-8-HELIX
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Three concerto detachable coils would not advance in the microcatheter.They are supposed to advance smoothly and deploy.The reason three were opened was the request of the physicians who were trying to embolize.Not sure the reasoning but none were successful.The three lot numbers involved are a551401, a225811, and a593437.

• 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: 7637446
• Report Number: 7637446
• Device Sequence Number: 11174006
• Product Code: KRD
• UDI-Device Identifier: 00847536013391
• UDI-Public: (01)00847536013391
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2018
• Report Date (Section F): 06/04/2018

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-3-8-HELIX
• Device Lot Number: A551401
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2018
• 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: 06/04/2018