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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 Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2019
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was selected for use.However, before inserting the device into the patient's body, it was noticed that some stent struts appeared to be flared.The procedure was completed with a different device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an express sd stented catheter.The balloon was loosely folded.The stent was secured between the markerbands.The hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined.The stent is damaged in the middle of the stent.Inspection of the device presented no damage or irregularities.
 
Event Description
It was reported that stent damage occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was selected for use.However, before inserting the device into the patient's body, it was noticed that some stent struts appeared to be flared.The procedure was completed with a different device.There were no patient complications 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
MDR Report Key9462259
MDR Text Key176380610
Report Number2134265-2019-15716
Device Sequence Number1
Product Code NIN
UDI-Device Identifier08714729484844
UDI-Public08714729484844
Combination Product (y/n)N
PMA/PMN Number
K152607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/07/2022
Device Model Number20188
Device Catalogue Number20188
Device Lot Number0024559426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Date Manufacturer Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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