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

Model Number	103-0608
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis #821542297:¿ equipment used: vis (m-78210) ¿ drawing(s) referenced: none ¿ as found condition: the mirage guidewire was returned for analysis within a shipping box and a plastic bio-pouch.¿ damage location details: the distal end of the mirage guidewire was found bent, with the outer coils stretched and the inner core wire broken.The mirage guidewire distal tip was found bent.The characteristic of the bent distal tip is consistent with shaping.¿ testing/analysis: the broken mirage guidewire was sent out for sem failure analysis.Per the sem report, the broken end failed via rotational overload.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿guidewire damage¿ report was confirmed.The guidewire can become damaged due to patient vessel tortuosity, aggressive removal of the guidewire, use of an incompatible catheter, or advancing or retrieving the device against resistance.From the damage observed on the returned mirage guidewire, force was applied.However, the cause of the guidewire damage could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that during the surgery, the mirage guidewire was found to be kink and was used smoothly after replacement.No patient symptoms or further complications were reported as a result of this event.Additional information received reported vessel tortuosity was normal.The device was prepared as indicated in the instructions for use (ifu).

• Brand Name: MIRAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21943540
• Report Number: 2029214-2025-01113
• Device Sequence Number: 20970922
• Product Code: DQX
• UDI-Device Identifier: 00763000294120
• UDI-Public: 00763000294120
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K124007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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: 12/05/2025
• Device Model Number: 103-0608
• Device Catalogue Number: 103-0608
• Device Lot Number: B537301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female