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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 H965SCH647070
Device Problems Retraction Problem (1536); Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 11/05/2014
Event Type  malfunction  
Event Description
It was reported that stent dislodgement occurred.An 8.0-21 carotid wallstent¿ was selected for use to treat the lesion.During preparation, the distal wire of the stent could not be drawn out and the physician noted that the stent was dislodged.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Event Description
It was reported that stent dislodgement occurred.An 8.0-21 carotid wallstent¿ was selected for use to treat the lesion.During preparation, the distal wire of the stent could not be drawn out and the physician noted that the stent was dislodged.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr.: device was received for evaluation.A visual examination of the returned device found that the outer sheath had been retracted and the stent had been fully deployed from the device.It was noted that the solid rod (packaging mandrel) was partially inserted through the tip so that 55mm of the solid rod was within the device.The proximal end of the solid rod was positioned at the proximal markerband.During analysis it was possible to remove the solid rod with an initial resistance met.The solid rod is within specification.Measurement of the outer diameter of the mandrel, found four measurements that were above the specification.These measurements corresponded with the section of the solid rod that was exiting the tip of the device as in its returned condition.It was also noted that the skived end of the mandrel was facing towards the distal end of the device.During manufacture, the skived end of the solid rod is inserted through the tip and should be facing towards the proximal end of the device.This means that the solid rod was in the incorrect orientation in the returned device.An indent was noted in the solid rod, proximal to the skived end.No other issues were noted with the profile of the solid rod.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be manufacturing related.(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 Key4287898
MDR Text Key5084991
Report Number2134265-2014-07275
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/08/2017
Device Model NumberH965SCH647070
Device Catalogue NumberSCH-64707
Device Lot Number16441506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2013
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 Age65 YR
Patient Weight58
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