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

Model Number	FA-55150-1030
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The marksman has not been returned for evaluation; product analysis cannot 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 a cavernous carotid fistula (ccf) was developed during intervention.The patient was undergoing treatment for an aneurysm in the communicating segment.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed as per the ifu.It was reported that during the procedure, a navien 5f was placed successfully.Afterward, a marksman and avigo guide wire were placed across the aneurysm without issue.The flush line was connected to the microcatheter and a pipeline flex was selected.The pipeline flex was placed in the hemostatic valve to allow hydration.The pipeline flex was advanced through the marksman with noted difficulty.When the pipeline flex reached the distal end of the marksman, it was reported that several attempts were made to deploy the device without success.The pipeline flex was attempted to be retracted.In the process of removal, it was reported that "since on the part that lay outside the patient, the marksman broke freeing the flow diverter on the patient's surgical clothing." afterward, a control angiogram was performed revealing a cavernous carotid fistula (ccf).It was reported that the ccf occurred due to the force implemented to remove the device.A new flow diversion device was placed to cover the ccf.The patient was reported to be asymptomatic, and extended hospitalization was not required.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9072677
• Report Number: 2029214-2019-00926
• Device Sequence Number: 1782140
• Product Code: KRA
• UDI-Device Identifier: 00847536008328
• UDI-Public: 00847536008328
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K091559
• 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): 09/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: FA-55150-1030
• Device Lot Number: A774561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/16/2019
• 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: Required Intervention
• Patient Age: 54 YR