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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 20188
Device Problem Premature Activation (1484)
Patient Problem No Patient Involvement (2645)
Event Date 11/05/2018
Event Type  malfunction  
Event Description
It was reported that stent partial premature deployment occurred.During preparation of a 5.0mmx19mmx90cm express sd renal/biliary stent when it was taken out from the hoop, it was noted that the stent was partially deployed.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
EXPRESS SD RENAL/BILIARY
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8103760
MDR Text Key128391229
Report Number2134265-2018-63216
Device Sequence Number1
Product Code NIN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/03/2020
Device Model Number20188
Device Catalogue Number20188
Device Lot Number0021212587
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2017
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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