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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 Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/14/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The target lesion was located in a bile duct artery.A 10mmx60mm wallflex biliary transhepatic stents was advanced for treatment.However, during procedure, the guidewire got stuck inside the stent delivery system.A non-bsc device was used to complete the procedure.No patient serious injury or adverse event were 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 Key8374431
Report Number2134265-2019-01787
Device Sequence Number11037441
Product Code FGE
UDI-Device Identifier08714729799344
UDI-Public08714729799344
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K112543
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) 02/27/2019
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 Date09/30/2020
Device Model Number20232
Device Catalogue Number20232
Device Lot Number22726880
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/14/2019
Initial Report FDA Received Date02/27/2019
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
GUIDEWIRE: RADIFOCUS 0.035INCH
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