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

Model Number NV-2-6-HELIX

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

Mid 60¿s y/o male with history of metastatic colon cancer.Procedure: y90 mapping angiogram with embolization.Device failed to deploy.No harm known to patient; another device used for procedure.Manufacturer response for device, vascular, for promoting embolization, concerto detachable coil system (per site reporter).Will obtain.

• Brand Name: CONCERTO DETACHABLE COIL SYSTEM
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 15742994
• MDR Text Key: 303150209
• Report Number: 15742994
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536044876
• UDI-Public: (01)00847536044876(17)250218(10)223821423
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV-2-6-HELIX
• Device Lot Number: 223821423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2022
• Date Report to Manufacturer: 11/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 91 KG