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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Patient Involvement (2645)
Event Date 12/16/2014
Event Type  malfunction  
Event Description
It was reported that partial deployment of stent occurred.A 10.0-24 carotid wallstent¿ was selected to treat the lesion but the stent has already been deployed inside the package.The procedure was completed with a different device.No patient complications were reported and patient's status was normal.
 
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: the outer sheath had been retracted 102mm from the tip and the stent had been deployed.No issues were noted with the profile of the stent.The solid rod was positioned inside the device and was exiting the monorail exit.During analysis the solid rod was withdrawn and its od was measured and was within specification.It was noted that the end of the solid rod facing the exit port was skived as expected.There was no sign of breakage on the solid rod.The solid rod passed the functional requirements prior to packaging.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).
 
Event Description
It was further reported that the stent was fully deployed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the stent was fully deployed.
 
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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 Key4418427
MDR Text Key21170921
Report Number2134265-2015-00237
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 12/16/2014
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 Date10/22/2017
Device Model NumberH965SCH647120
Device Catalogue NumberSCH-64712
Device Lot Number16914794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/23/2015
Initial Date FDA Received01/14/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/28/2015
04/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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