MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number	105-5081-130
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was not returned for evaluation; product analysis could not be performed.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 it was unable to visualize the tip of the rebar catheter under fluoroscopy.They attempted to magnify the image but were still unsuccessful locating the micro tip.A new catheter was used to complete the procedure.This event occurred during the treatment of an arteriovenous malformation of a left subclavian artery, vessel diameter 10mm.The anatomy was reported to have been normal in tortuosity.The device was discarded at the site.There was no allegation that the device was damaged prior to use.The reported device and any accessory devices prepared as indicated in the instructions for use (ifu).The tip had been shaped by the user.The catheter flushed as indicated in the ifu.

• Brand Name: REBAR
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8511911
• Report Number: 2029214-2019-00344
• Device Sequence Number: 11017690
• Product Code: KRA
• UDI-Device Identifier: 00847536026810
• UDI-Public: 00847536026810
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 01/27/2021
• Device Model Number: 105-5081-130
• Device Lot Number: A773397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1