MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 1.50MM X 15MM; CATHETER, BALLOON TYPE

Model Number	M0032072215150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Subarachnoid (1893)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 3 of 3 reports.The subject device is not available.
Event or Problem Description
The patient underwent stent assisted balloon(subject device) angioplasty of the basilar trunk artery stenosis with the successful implantation of the first stent.It was reported that during the placement of the second stent, the stent failed to open and hence it was not implanted.The next day of the procedure, trace amount of subarachnoid hemorrhage within interpeduncular and prepontine cistern was observed.The hemorrhage was resolved without any residual effects.No treatment was administered in the physician¿s opinion, the cause of the hemorrhage is related to the procedure; however, relationship to the stent and the balloon is unknown.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, hemorrhage is a known risk associated with an endovascular procedure and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
The patient underwent stent assisted balloon(subject device) angioplasty of the basilar trunk artery stenosis with the successful implantation of the first stent.It was reported that during the placement of the second stent, the stent failed to open and hence it was not implanted.The next day of the procedure, trace amount of subarachnoid hemorrhage within interpeduncular and prepontine cistern was observed.The hemorrhage was resolved without any residual effects.No treatment was administered in the physician¿s opinion, the cause of the hemorrhage is related to the procedure; however, relationship to the stent and the balloon is unknown.

• Brand Name: FG GATEWAY OTW US 1.50MM X 15MM
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 6874367
• Report Number: 3008853977-2017-00031
• Device Sequence Number: 659736
• Product Code: GBA
• UDI-Device Identifier: 08714729791300
• UDI-Public: (01)08714729791300(17)171001(10)17331954
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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: 10/01/2017
• Device Model Number: M0032072215150
• Device Catalogue Number: M0032072215150
• Device Lot Number: 17331954
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 11/21/2017
• 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