MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, EMBOLIZATION, VASCULAR

Model Number	NV-6-20-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto coil was returned without the introducer sheath.Therefore, any contributing factors from the introducer sheath could not be assessed.The concerto pushwire was found to be broken at break indicator and retained by release wire.The concerto implant coil appeared to be detached from pushwire.The implant coil was not returned therefore; any contributing factors could not be assessed.No other anomalies were observed.There was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed as the introducer sheath and implant coil were not returned for analysis.The root cause could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the concerto coil was stuck in the hub of the microcatheter.It was unknown how the procedure was completed.No patient injury was reported as a result of the event.It was reported the concerto coil was stuck in the introducer sheath.No more information was available.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10897716
• Report Number: 2029214-2020-01180
• Device Sequence Number: 14204652
• Product Code: KRD
• UDI-Device Identifier: 00847536033573
• UDI-Public: 00847536033573
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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 Expiration Date: 07/11/2022
• Device Model Number: NV-6-20-HELIX
• Device Catalogue Number: NV-6-20-HELIX
• Device Lot Number: A863326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1