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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 24672
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  malfunction  
Event Description
It was reported that balloon leak occurred.A 3.0 x 120, 135cm mustang balloon catheter was advanced for dilation.During the procedure, upon first inflation the balloon was found leaking.The device was tested outside the body.It was confirmed that the leak was within balloon material.The procedure was completed with a different device.No complications were reported, and the patient was stable.
 
Manufacturer Narrative
E1: initial reported address 1:(b)(6).
 
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Brand Name
MUSTANG
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
pmt 741 persiaran cassia selat
bandarcassia, pulau pinan 14110
MY   14110
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18987722
MDR Text Key338734054
Report Number2124215-2024-18313
Device Sequence Number1
Product Code FGE
UDI-Device Identifier08714729793816
UDI-Public08714729793816
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K103751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24672
Device Catalogue Number24672
Device Lot Number0031832181
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2023
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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