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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY TRANSHEPATIC; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY TRANSHEPATIC; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 20232
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/04/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent profile problem occurred.A 10mmx60mm wallflex biliary transhepatic stent was advanced for treatment.However, it was noted that the size of the stent was too hard to determine based on shortening.The device was removed from the patient.The procedure was completed with a different device.There were no patient complications nor injuries reported.
 
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Brand Name
WALLFLEX BILIARY TRANSHEPATIC
Common Device Name
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9739730
Report Number2134265-2020-01873
Device Sequence Number1802017
Product Code FGE
UDI-Device Identifier08714729799344
UDI-Public08714729799344
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K112543
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/21/2020
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 Date11/25/2021
Device Model Number20232
Device Catalogue Number20232
Device Lot Number0024832769
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/04/2020
Initial Report FDA Received Date02/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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