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

Lot Number B091008

Device Problems Failure to Advance (2524); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Event Description

Concerto coil failed to go through the catheter to deploy.

Event Description

Concerto coil failed to go through the catheter to deploy.

• Brand Name: CONCERTO
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11581042
• MDR Text Key: 242689723
• Report Number: 11581042
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: B091008
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29930 DA