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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 H965SCH647080
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2013
Event Type  malfunction  
Event Description
It was reported that a premature stent deployment occurred.Following the insertion of a 7f unspecified sheath, a 8.0-29 carotid wallstent stent was introduced through the sheath, however, the stent prematurely deploys outside the sheath.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
The device was returned for evaluation.A visual examination of the returned device found that the stent was fully mounted onto the device.No issues were noted with the profile of the returned device.During analysis, it was possible to insert the device through a recommended size 7 french introducer sheath without issue.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
It was reported that a premature stent deployment occurred.Following the insertion of a 7f unspecified sheath, a 8.0-29 carotid wallstent stent was introduced through the sheath, however, the stent prematurely deploys outside the sheath.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
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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
ingrid matte
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key3585782
MDR Text Key4037271
Report Number2134265-2013-09802
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/17/2015
Device Model NumberH965SCH647080
Device Catalogue NumberSCH-64708
Device Lot Number14831644
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
7F SHEATH
Patient Age65 YR
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