MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 0.14 GUIDEWIRES; WIRE, GUIDE, CATHETER

Model Number	103-0606-200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
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 when treating a stenotic lesion, the guidewire tip was found to be broken when it was introduced to the lesion.Another guidewire was used and the operation went smoothly.No patient symptoms or complications were associated with this event.
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
Additional information received clarified that all the pieces of the guidewire were removed from the patient.No surgical or medical intervention was required to remove the guidewire.The device was prepared as indicated in the ifu.The patient was undergoing treatment for a v4 vertebral artery lesion.The patient's vessel tortuosity was moderate.
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): an avigo guidewire was returned for analysis within a shipping box; within a sealed biohazard pouch and within a dispenser track.Visual inspection/damage location details: no bends or kinks were found with the pushwire.The pushwire ptfe coating and the distal polymer jacket appears to be intact.The guidewire distal tip appeared to have been separated when compared to the product drawing.The total length of the avigo guidewire was measured to be ~196.4cm.The distal tip approximate separated length was found to be ~8.6cm.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿guidewire separation/break¿ was confirmed.However, the root cause could not be determined.Possible cause of ¿guidewire separation/break¿ is advancing or withdrawing guidewire against resistance in catheter.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: 0.14 GUIDEWIRES
• 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: 22130864
• Report Number: 2029214-2025-01288
• Device Sequence Number: 7357315
• Product Code: DQX
• UDI-Device Identifier: 00763000338275
• UDI-Public: (01)00763000338275(17)271012(10)B802495
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113454
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2025

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 Model Number: 103-0606-200
• Device Catalogue Number: 103-0606-200
• Device Lot Number: B802495
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 07/17/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/21/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2024
• 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 Sex: Male