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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW JP 2.00MM X 9MM; CATHETER, BALLOON TYPE
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BOSTON SCIENTIFIC - MINN FG GATEWAY OTW JP 2.00MM X 9MM; CATHETER, BALLOON TYPE Back to Search Results
Catalog Number M0032072009200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 11/19/2014
Event Type  Injury  
Event Description
It was reported that post dilation of the right middle cerebral artery, vessel dissection occurred.The physician deployed a stent in response to the event without clinical consequences to the patient.
 
Event Description
It was reported that post dilation of the right middle cerebral artery, vessel dissection occurred.The physician deployed a stent in response to the event without clinical consequences to the patient.
 
Manufacturer Narrative
Subject device was disposed.
 
Event Description
It was reported that post dilation of the right middle cerebral artery, vessel dissection occurred.The physician deployed a stent in response to the event without clinical consequences to the patient.
 
Manufacturer Narrative
The subject device is not available; therefore analysis cannot be performed.From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse.There is also no indication that the subject device malfunctioned.However, vessel dissection is a known risk associated with such procedures and noted as such in the directions for use (dfu).Therefore, a root cause of anticipated procedural complication has been assigned to the event.
 
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Brand Name
FG GATEWAY OTW JP 2.00MM X 9MM
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 Key4614672
MDR Text Key5590417
Report Number3008853977-2015-00131
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,Followup
Report Date 03/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/12/2016
Device Catalogue NumberM0032072009200
Device Lot Number15946533
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2013
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 Age74 YR
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