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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 04/27/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
It was reported that both a marksman 150cm and navien 058 were used during the procedure. It was not reported which catheter was being used at the time of aneurysm neck bleeding. Brand name: marksman catheter, product code: krd, model number: fa-55150-1030, 510(k) number: k091559. Brand name: navien intracranial support catheter, product code: dqy, model number: unknown, 510(k) number: k110055. The devices have not been returned for evaluation; product analysis cannot be performed. Based on the reported information, there did not appear to have been any defect of the devices during use. The event occurred in the patient intra-procedurally and its cause could not be conclusively determined from the reported information.
Event Description
Medtronic received report that a patient experienced aneurysm neck bleeding during catheterization of an aneurysm for coiling. The patient subsequently underwent endovascular coiling. There were no reports of patient symptoms in connection with this event. The patient reportedly recovered without sequelae. The patient was undergoing a procedure to treat a pseudoaneurysm in a left cerebral artery. A navien 058 guide catheter and marksman 150cm were used during the procedure. It was not reported which microcatheter was being used at the time of the bleed.
Manufacturer Narrative
Event description - additional information. The aneurysm neck bleeding did not occur in association with any medtronic products. There have been no allegations against any medtronic products. If information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received additional event information: the aneurysm bleeding was due to a perforation by another manufacturer's microcatheter. The perforation occurred prior to use of any medtronic devices.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key6599986
MDR Text Key105944198
Report Number2029214-2017-00716
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/30/2017 Patient Sequence Number: 1