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	Foreign Body In Patient (2687)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that during accessing of the left internal carotid artery (ica), the avigo guidewire could not be push up (advanced).The avigo guidewire was retrieved and noticed to have the distal tip (around 3-4mm) broken.The distal section of the avigo guidewire was left inside the vessel.(vessel lica tortuous).The patient was reported to have asymptomatic.

• 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: 9941967
• Report Number: 2029214-2020-00352
• Device Sequence Number: 3882124
• Product Code: DQX
• UDI-Device Identifier: 00847536004764
• UDI-Public: 00847536004764
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K113454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: 103-0606-200
• Device Lot Number: A872157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other