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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 H965SCH647130
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the carotid artery.A 10.0mmx31mm carotid wallstent¿ was advanced for treatment; however the stent was found damaged.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: the device was received with the stent fully constrained on the delivery device.No damage was evident.The investigator deployed the stent without issue.The stent was visually and microscopically examined and no issues were identified.A visual and tactile inspection identified no issues along the length of the device.No issues were identified during the product analysis.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 stent damage occurred.The target lesion was located in the carotid artery.A 10.0mmx31mm carotid wallstent¿ was advanced for treatment; however the stent was found damaged.The procedure was completed with another of the same 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
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5935648
MDR Text Key54170158
Report Number2134265-2016-07829
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 company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/21/2018
Device Model NumberH965SCH647130
Device Catalogue NumberSCH-64713
Device Lot Number0017383055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age72 YR
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