MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 1.50MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number	M0032072209150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Subarachnoid (1893)
Date of Event	05/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 out of 2 reports for this event.The device was disposed.
Event or Problem Description
Following angioplasty with a balloon catheter (subject device), a stent was placed across the target 90% stenosed right posterior cerebral artery (pca) lesion.It was reported that a subarachnoid hemorrhage (sah) occurred after the stent deployment.A computer tomography (ct) scan confirmed sah with no evidence of a new stroke or mass effect.The sah location was right occipital-right parietal lobe distal to the treated area.Intra-arterial injection of tamponade and protamine were given to the patient.There were no clinical symptoms and on the same day, the event was resolved without residual effects.Six days post procedure, the patient was discharged.The event was reported as related to the procedure but unrelated to either device.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, hemorrhage is a known risk associated with endovascular procedures and is listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
Event or Problem Description
Following angioplasty with a balloon catheter (subject device), a stent was placed across the target 90% stenosed right posterior cerebral artery (pca) lesion.It was reported that a subarachnoid hemorrhage (sah) occurred after the stent deployment.A computer tomography (ct) scan confirmed sah with no evidence of a new stroke or mass effect.The sah location was right occipital-right parietal lobe distal to the treated area.Intra-arterial injection of tamponade and protamine were given to the patient.There were no clinical symptoms and on the same day, the event was resolved without residual effects.Six days post procedure, the patient was discharged.The event was reported as related to the procedure but unrelated to either device.

• Brand Name: FG GATEWAY OTW US 1.50MM X 9MM
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 5691806
• Report Number: 0002134265-2016-00007
• Device Sequence Number: 315568
• Product Code: GBA
• UDI-Device Identifier: 08714729791201
• UDI-Public: (01)08714729791201(17)180831(10)18269870
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2016

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 Expiration Date: 08/31/2018
• Device Catalogue Number: M0032072209150
• Device Lot Number: 18269870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 07/19/2016
• 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; Required Intervention
• Patient Age: 50 YR