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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA BILIARY; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION FLEXIMA BILIARY; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M00539310
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a flexima biliary pre-loaded stent was to be used during a procedure on an unknown date.During preparation, the packaging seal has peeled off and has stuck to another product upon opening the package.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of the packaging seal compromised.
 
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Brand Name
FLEXIMA BILIARY
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
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18446494
MDR Text Key331939235
Report Number3005099803-2023-06965
Device Sequence Number1
Product Code FGE
UDI-Device Identifier08714729162629
UDI-Public08714729162629
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K965147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00539310
Device Catalogue Number3931
Device Lot Number0032813706
Was Device Available for Evaluation? No
Date Manufacturer Received12/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2023
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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