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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT?; STENT, CAROTID
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BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT?; STENT, CAROTID Back to Search Results
Model Number H965SCH647070
Device Problem Premature Activation (1484)
Patient Problem No Patient Involvement (2645)
Event Date 02/16/2015
Event Type  malfunction  
Event Description
It was reported that stent inadvertent deployment occurred.An 8.0x21 carotid wallstent® was selected for use to treat the target lesion.During preparation, the physician noted that the stent was "disengaged from the balloon".The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
(b)(6).(b)(4).
 
Event Description
It was reported that stent inadvertent deployment occurred.An 8.0x21 carotid wallstent® was selected for use to treat the target lesion.During preparation, the physician noted that the stent was "disengaged from the balloon".The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: a visual examination of the returned device found that the outer sheath had been retracted past the stent holder and that the stent had been deployed.The stent was not returned for analysis.It was noted that the valve body had been retracted past the black limit marker on the shaft which would result in the stent being deployed.The packaging mandrel was returned partially inserted through the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
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Brand Name
CAROTID WALLSTENT?
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4616792
MDR Text Key5698832
Report Number2134265-2015-01322
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/22/2018
Device Model NumberH965SCH647070
Device Catalogue NumberSCH-64707
Device Lot Number17147449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2015
Initial Date FDA Received03/19/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/28/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2014
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
JR 3.5 8 FR GUIDE CATHETER; FILTER WIRE EZ GUIDE WIRE
Patient Weight72
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