MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR AXIUM 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	QC-20-50-3D
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the axium implant coil could not pass through an echelon 14 microcatheter and then detached and stretched inside the microcatheter as the coil was retracted into the introducer sheath.Prior to the event, two axium coils had passed smoothly through the same microcatheter.The product was replaced, and the procedure was successfully completed.No patient injury was reported as a result of the event.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 91618
• MDR Report Key: 8010129
• Report Number: 2029214-2018-00893
• Device Sequence Number: 1395274
• Product Code: KRD
• UDI-Device Identifier: 00836462010529
• UDI-Public: 00836462010529
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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: 02/16/2019
• Device Model Number: QC-20-50-3D
• Device Catalogue Number: QC-20-50-3D
• Device Lot Number: A229019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70