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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 Problems Premature Activation (1484); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that the stent partially deployed.The physician tried to advance a carotid wallstent¿ delivery system to the target lesion, however it was unable to cross and was successfully removed.It was then noted that despite no attempt to release the stent, the distal struts were visable.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: a visual examination of the returned device found that the stent was partially deployed by 1mm and that the distal stent wires were kinked.The outer sheath was probably pushed proximally exposing the stent wires during the attempt to cross the lesion.Dried blood was noted along the shaft and no issues were noted with the profile of the delivery device.Measurement of the od of the device at various locations found that all measurements were within the system profile specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that the stent partially deployed.The physician tried to advance a carotid wallstent¿ delivery system to the target lesion, however it was unable to cross and was successfully removed.It was then noted that despite no attempt to release the stent, the distal struts were visable.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is 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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4044973
MDR Text Key4725095
Report Number2134265-2014-05297
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/09/2017
Device Model NumberH965SCH647080
Device Catalogue NumberSCH-64708
Device Lot Number17034899
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2014
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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