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

Model Number	103-0608
Medical Device Problem Codes	Break (1069); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the mirage guidewire had difficult navigation and a thready wire was found at the tip.It was reported that the operator crossed the first bend at the origin of right m2 segment, then after 1 cm again there was acute bend which was crossed by the mirage and marathon catheter.At the next bend of the m3 junction, the mirage didn't cross.The operator attempted 3-4 times but it was no use.At one point the mirage was stuck in the m3 junction, and the operator took out the mirage and marathon from the system.They noticed there was a thready wire on the mirage at the tip.The device was kept aside, and a new mirage was used to finish the case. the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).
Event or Problem Description
Additional information was received that the patient was being treated for an aneurysm of the right m2.Vessel tortuosity was severe.It was noted that the tread was still attached to the guidewire but also noted that material was broken off.The cause of the event was not determined.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the mirage guidewire was returned for analysis within a shipping box, an opened mirage outer carton (b538442), an opened mirage inner pouch (b538442), and a dispenser coil.¿ damage location details: no bends or kinks were found with the mirage guidewire.An unknown material was found adhered to the guidewire distal tip.No breaks or separations were found with the mirage guidewire.¿ testing/analysis: the unknown material was sent out for ftir analysis and found to be gelatin, purified calfskin.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿difficult navigation¿ and ¿guidewire separation/break¿ reports could not be confirmed.It is possible that the patient¿s ¿severe¿ vessel tortuosity contributed to the reported difficult navigation; however, the cause could not be determined.Regarding the material found with the mirage guidewire, the origin of the material could not be identified.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.

• 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: 20447874
• Report Number: 2029214-2024-01870
• Device Sequence Number: 18266951
• Product Code: DQX
• UDI-Device Identifier: 00763000294120
• UDI-Public: 00763000294120
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup
• Report Date (Section B): 01/07/2025

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: 12/02/2025
• Device Model Number: 103-0608
• Device Catalogue Number: 103-0608
• Device Lot Number: B538442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 12/12/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/01/2024; 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2023
• 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: 19 YR
• Patient Sex: Female
• Patient Weight: 59 KG