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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD VASCULAR; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION EXPRESS LD VASCULAR; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 20212
Device Problem Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
Event Type  malfunction  
Event Description
It was reported that the stent was spontaneously released.An 8.0x40x135 cm express ld vascular stent balloon expandable was selected for use.However, the stent was spontaneously released during device manipulation.No complications were reported.
 
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Brand Name
EXPRESS LD VASCULAR
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19118855
MDR Text Key340823754
Report Number2124215-2024-21658
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20212
Device Catalogue Number20212
Device Lot Number0031197102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2023
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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