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 Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2020
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 a report that the tip of the avigo guidewire broke.No additional event information was provided at the time of the report.

• 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
• MDR Report Key: 10496201
• Report Number: 2029214-2020-00895
• Device Sequence Number: 17039959
• Product Code: DQX
• UDI-Device Identifier: 00847536004764
• UDI-Public: 00847536004764
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2020

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: 07/12/2022
• Device Model Number: 103-0606-200
• Device Catalogue Number: 103-0606-200
• Device Lot Number: A930324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1