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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FG GATEWAY MR JP 2.00MM X 20MM; CATHETER, BALLOON TYPE
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BOSTON SCIENTIFIC CORPORATION FG GATEWAY MR JP 2.00MM X 20MM; CATHETER, BALLOON TYPE Back to Search Results
Catalog Number M0032072120200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 09/25/2014
Event Type  Injury  
Event Description
It was reported that a vessel dissection occurred after a balloon catheter (subject device) was used for a left vertebral artery angioplasty.A stent was placed across the lesion; however, in-stent thrombosis was noted.The vessel patency was restored without additional treatment.
 
Event Description
It was reported that a vessel dissection occurred after a balloon catheter (subject device) was used for a left vertebral artery angioplasty.A stent was placed across the lesion; however, in-stent thrombosis was noted.The vessel patency was restored without additional treatment.
 
Manufacturer Narrative
The device is not available to the manufacturer.
 
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The device remained implanted and was not available for analysis.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.Vessel dissection is a known and anticipated complication to these types of procedures and is noted in the labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.
 
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Brand Name
FG GATEWAY MR JP 2.00MM X 20MM
Type of Device
CATHETER, BALLOON TYPE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
one boston scientific place
natick MA 01760
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
one boston scientific place
natick MA 01760
Manufacturer Contact
alyson harris
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key4436835
MDR Text Key5311834
Report Number3008853977-2015-00020
Device Sequence Number1
Product Code GBA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
H050001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/08/2015
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
Device Operator Health Professional
Device Expiration Date11/15/2014
Device Catalogue NumberM0032072120200
Device Lot Number14834388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received01/21/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
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