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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 H965SCH647120
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2014
Event Type  malfunction  
Event Description
It was reported that during prep for a stenting treatment procedure, premature stent deployment occurred.The physician flushed the carotid wallstent 10.0-24 outside of the patient when it was noticed that 1mm of the stent deployed inside the outer sheath.The physician attempted to recapture the stent without success.The procedure was completed with another of the same device.There were no reported patient complications and the patient status is stable.
 
Event Description
It was reported that during prep for a stenting treatment procedure, premature stent deployment occurred.The physician flushed the carotid wallstent 10.0-24 outside of the patient when it was noticed that 1mm of the stent deployed inside the outer sheath.The physician attempted to recapture the stent without success.The procedure was completed with another of the same device.There were no reported patient complications and the patient status is stable.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by manufacturer: a visual examination identified the stent was partially deployed with its distal stent wires protruding from the distal end of the outer sheath.It appeared that the stent had moved distally along the shaft and its proximal end was not positioned at the stent cup.During analysis when the outer was partially retracted and an attempt was made to fully reconstrain the stent, the stent was not fully reconstrained due to its distal movement on the shaft.The stent was then fully deployed and no issues were noted with the inner lumen or stent cup or stent holder.No issues were noted with the profile of the stent including its length.Slight bending of the metal shaft was also noted.The distal movement of the stent and bend in the metal shaft is consistent with excessive handling of 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 prior to 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 Key4110633
MDR Text Key4758867
Report Number2134265-2014-06098
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
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 08/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/10/2017
Device Model NumberH965SCH647120
Device Catalogue NumberSCH-64712
Device Lot Number0016598145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2013
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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