MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MIRAGE; WIRE, GUIDE, CATHETER

Model Number	103-0608
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mirage guidewire pusher coating was found accordioned and broken throughout the pusher length.No bends or kinks were found with the pusher.The mirage guidewire coil tip was found slightly damaged.Under magnification, the fibers returned within the glass vial was confirmed to be pieces of the coating.The customer report of fibers was confirmed as the device was found to have coating peeling.The fibers were found to be fragments of the coating.In addition, the coil tip was found slightly damaged.The cause of the peeling/damages could not be determined.It is possible that the coating and coil tip became damaged due to resistance during insertion.Customer did not report any resistance during the procedure.As the marathon micro catheter used in the event was not returned, any contribution of the marathon micro catheter towards resistance/damage could not be confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that there were rigid, plastic threads adhered to the mirage guidewire after removal from the marathon microcatheter.The patient was undergoing diagnostic treatment.It was noted the patient's vessel tortuosity was normal.It was reported that there was no problem when performing the diagnostic procedure and inserting the mirage guide into the marathon microcatheter, it navigated perfectly and achieved the target.However, when the guidewire was removed, it was observed that pieces of thread adhered to the guidewire.At first, it was thought to be part of a gauze, and the guidewire was re-inserted in the microcatheter to continue the procedure.When the wire was removed to finish the procedure, more of these threads were observed.When touched, it was noted the threads were rigid and looked like plastic detached from the guidewire.No material such as onyx, dmso, or contrast were used, only nacl 0.9%.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a long sheath, marathon microcatheter.

• Brand Name: MIRAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12100355
• Report Number: 2029214-2021-00801
• Device Sequence Number: 3965938
• Product Code: DQX
• UDI-Device Identifier: 00763000294120
• UDI-Public: 00763000294120
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K002212
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: 01/28/2023
• Device Model Number: 103-0608
• Device Catalogue Number: 103-0608
• Device Lot Number: B046271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1