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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 26280
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 as the correct date was not provided.
 
Event or Problem Description
It was reported that stent migration occurred.A 16x60/9fr wallstent endoprosthesis stent was advanced for treatment.However, the stent jumped a lot after deployment.Another stent was used to completed the case.There were no patient complications nor injuries reported.
 
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Brand Name
WALLSTENT ENDOPROSTHESIS
Common Device Name
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10224671
Report Number2134265-2020-08785
Device Sequence Number514959
Product Code MAF
UDI-Device Identifier08714729204046
UDI-Public08714729204046
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K152842
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/02/2020
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 Date01/12/2022
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0025028384
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/29/2020
Initial Report FDA Received Date07/02/2020
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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