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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 Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/28/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the stent dislodged.An express sd renal/biliary stent was selected for use for an angioplasty and stent procedure in the left renal artery.During the procedure, the stent became dislodged off of the balloon at the location of the left renal artery.The stent expanded with no additional problems and 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 Key8161980
Report Number2134265-2018-64081
Device Sequence Number19256779
Product Code NIN
UDI-Device Identifier08714729484844
UDI-Public08714729484844
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K152607
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/13/2018
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
Operator of Device Health Professional
Device Expiration Date09/13/2020
Device Model Number20188
Device Catalogue Number20188
Device Lot Number0021133230
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/28/2018
Initial Report FDA Received Date12/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
300CM V-18 GUIDEWIRE; 5X20MM STERLING RX PRE-DILATATION BALLOON; 6FR X 11CM SHEATH; 6FR X 55CM LIMA MACH 1 GUIDE CATHETER
Patient Age84 YR
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