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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC Back to Search Results
Model Number 20226
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2020
Event Type  malfunction  
Event Description
It was reported that stent moved on balloon occurred via medwatch mw5097294.A 6.0 x 40 x 75cm express ld iliac stent was advanced for treatment.However, the balloon moved forward on the shaft of the balloon before it could deploy.There were no patient complications reported.
 
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Brand Name
EXPRESS LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10875869
MDR Text Key217376099
Report Number2134265-2020-16150
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392156
UDI-Public08714729392156
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/20/2020
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
Device Operator Health Professional
Device Expiration Date02/02/2023
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0025143207
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2020
Initial Date FDA Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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