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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 Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device evaluated by mfr.: the complaint device was not received for analysis.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 catheter entrapment occurred.The target lesion was located in the carotid artery.After a non-bsc guide wire was placed, a 10.0-24 carotid wallstent¿ was advanced to treat the lesion.However, the device became stuck and was unable to pass over the guide wire.Subsequently, the whole system was removed and 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 Key6766983
MDR Text Key81823864
Report Number2134265-2017-07626
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
Report Date 07/17/2017
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 Date03/30/2020
Device Model NumberH965SCH647120
Device Catalogue NumberSCH-64712
Device Lot Number0019780452
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/17/2017
Initial Date FDA Received08/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2016
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 Age86 YR
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