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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
Medical Device Problem Codes Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/08/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right renal artery.A 5.0mmx19mmx90cm express sd renal/biliary drug-eluting stent was advanced through a tight stenosis.The stent would not advance through the tight stenosis.The device was being removed, it was noted during removal that the stent came off the balloon.The dislodged stent was snared out of the patient.The procedure was completed with a different device.There were no patient complications reported.
 
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Brand Name
EXPRESS SD RENAL/BILIARY
Common Device Name
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9371163
Report Number2134265-2019-14427
Device Sequence Number14002544
Product Code NIN
UDI-Device Identifier08714729390480
UDI-Public08714729390480
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K152607
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/08/2022
Device Model Number20188
Device Catalogue Number20188
Device Lot Number0023615185
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/11/2019
Initial Report FDA Received Date11/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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