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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 06/20/2014
Event Type  malfunction  
Event Description
It was reported during a stenting treatment procedure, partial stent deployment occurred.An 8.0-29 carotid wallstent couldn't be released to treat the lesion.The guidewire was in the catheter's tip; however, it was not extending from the tip.The carotid wallstent was then withdrawn and it was then noted that the stent began to deploy in an unspecified location.No patient complications were reported and the procedure was completed with a different device.
 
Manufacturer Narrative
Device evaluation by manufacturer: 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
(b)(4).
 
Event Description
It was reported during a stenting treatment procedure, partial stent deployment occurred.An 8.0-29 carotid wallstent couldn't be released to treat the lesion.The guidewire was in the catheter's tip; however, it was not extending from the tip.The carotid wallstent was then withdrawn and it was then noted that the stent began to deploy in an unspecified location.No patient complications were reported and the procedure was completed with a different device.
 
Manufacturer Narrative
Device evaluated by manufacturer: examination of the returned complaint device revealed a visual examination of the returned device found that the stent was fully mounted.It was noted that a piece of packaging mandrel measuring 45mm was inside the inner, located between 52mm and 97mm proximal to the tip.The mandrel was unable to be removed from the device by insertion of a guidewire so the outer and inner was dissected in stages so that the mandrel could be revealed without damaging it in the process.The section of mandrel could not be entirely removed from the inner as it was stuck inside one section of inner.The section of mandrel that was inside the device measured 43mm.Measurement of the outer diameter of the mandrel, starting at the broken end facing away from the tip and measuring towards the unbroken end facing towards the tip are measured above the specification.The manufacturing record for this product has been reviewed and no issues or discrepancies were found.This review did not identify any failure of the product to meet its material, assembly or performance specifications.The most probable cause of the reported difficulties may be due to manufacturing as the product fails to meet specification.(b)(4).
 
Event Description
It was reported during a stenting treatment procedure, partial stent deployment occurred.An 8.0-29 carotid wallstent¿ couldn't be released to treat the lesion.The guidewire was in the catheter's tip; however, it was not extending from the tip.The carotid wallstent was then withdrawn and it was then noted that the stent began to deploy in an unspecified location.No patient complications were reported and the procedure was completed with a different device.
 
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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 Key3934676
MDR Text Key4576971
Report Number2134265-2014-04293
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeBR
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 06/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2014
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/10/2017
Device Model NumberH965SCH647080
Device Catalogue NumberSCH-64708
Device Lot Number0016447667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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