Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 2.75MM X 15MM; CATHETER, BALLOON TYPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 2.75MM X 15MM; CATHETER, BALLOON TYPE Back to Search Results
Catalog Number M0032072215270
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)
Event Date 03/01/2015
Event Type  Injury  
Event Description
The physician successfully performed a balloon (subject device) angioplasty of the target basilar trunk lesion to treat 74% proximal stenosed lesion and 79% distal stenosed lesion.Following angioplasty, the first stent was placed across the distal lesion and the second stent was placed to cover the proximal lesion in overlapping fashion.After the procedure, the basilar trunk had 35% residual stenosis.There was no device malfunction and no patient complication noted during the procedure.However, several hours post procedure, the patient had right sided weakness.Imaging demonstrated an ischemic thromboembolic left pontine perforator/lacunar stroke with mild mass effect.The next day, new left cerebellar and vermian infarcts with small right temporo-occipital subarachnoid hemorrhage (sah) were found.The stroke was treated using medical therapy (not specified).The physician stated that the reported stroke related to use of the subject balloon catheter; however, the relations to the stent and the procedure are unknown.
 
Manufacturer Narrative
The device was not available for analysis.The device history record review confirms that the device met all material, assembly and performance specifications.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.Hemorrhage, stroke and neurological deficit are known and anticipated complications to these types of procedures and are listed as such in the device directions for use and/or device labeling.Therefore, the root cause of this complaint will be classified as anticipated patient complication.
 
Event Description
The physician successfully performed a balloon (subject device) angioplasty of the target basilar trunk lesion to treat 74% proximal stenosed lesion and 79% distal stenosed lesion.Following angioplasty, the first stent was placed across the distal lesion and the second stent was placed to cover the proximal lesion in overlapping fashion.After the procedure, the basilar trunk had 35% residual stenosis.There was no device malfunction and no patient complication noted during the procedure.However, several hours post procedure, the patient had right sided weakness.Imaging demonstrated an ischemic thromboembolic left pontine perforator/lacunar stroke with mild mass effect.The next day, new left cerebellar and vermian infarcts with small right temporo-occipital subarachnoid hemorrhage (sah) were found.The stroke was treated using medical therapy (not specified).The physician stated that the reported stroke related to use of the subject balloon catheter; however, the relations to the stent and the procedure are unknown.
 
Manufacturer Narrative
The device is not available to the manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FG GATEWAY OTW US 2.75MM X 15MM
Type of Device
CATHETER, BALLOON TYPE
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINN
one scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINN
one scimed place
maple grove MN 55311
Manufacturer Contact
kathleen shin
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key4638272
MDR Text Key5746025
Report Number3008853977-2015-00143
Device Sequence Number1
Product Code GBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H050001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/09/2015
Device Catalogue NumberM0032072215270
Device Lot Number15373167
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TWO GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC); TWO WINGSPAN STENTS (STRYKER)
Patient Outcome(s) Required Intervention;
Patient Age60 YR
-
-