MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX058-115-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	11/12/2019
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.Mdrs related to this event: 2029214-2019-01186 2029214-2019-01187; 2029214-2019-01188.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that a patient developed a fistula during a procedure.The patient was undergoing embolization treatment for an unruptured amorphous aneurysm located in right internal carotid artery (ica) landing zone distal 3.2mm proximal 4.7mm.The vessel was observed moderately tortuous.It was reported that the devices were prepared as indicated in the ifu.The physician advanced a guide catheter and microcatheter.A run with contrast revealed a fistula that the physician believes was catheter induced.The physician decided to ¿sack¿ the vessel as the right ica on imaging was being well fed from contralateral flow.Right ica was sacrificed; the patient¿s contralateral flow was feeding right circulation.There were no patient symptoms or complications associated with this event.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9407258
• Report Number: 2029214-2019-01188
• Device Sequence Number: 11375118
• Product Code: DQY
• UDI-Device Identifier: 00847536017795
• UDI-Public: 00847536017795
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110055
• 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): 12/03/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: RFX058-115-08
• Device Lot Number: A590153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/03/2019
• 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
• Patient Age: 73 YR