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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 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that inadvertent stent deployment occurred.During unpacking of a 10.0-24 carotid wallstent, it was noted that the stent was detached from the stent delivery system.The procedure was completed with another of the same.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The stent had already been deployed and was returned with the delivery device.A visual examination identified no issues with the stent or the stent holder.The stent impression was evident on the stent holder.A visual and tactile examination found no kinks or other damage along the length of the catheter.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
 
Event Description
It was reported that inadvertent stent deployment occurred.During unpacking of a 10.0-24 carotid wallstent¿, it was noted that the stent was detached from the stent delivery system.The procedure was completed with another of the same.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 Key7186869
MDR Text Key97386990
Report Number2134265-2017-13257
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 company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/20/2017
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 Date03/15/2021
Device Model NumberH965SCH647120
Device Catalogue NumberSCH-64712
Device Lot Number21133435
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2017
Initial Date FDA Received01/12/2018
Supplement Dates Manufacturer Received01/16/2018
Supplement Dates FDA Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2017
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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