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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 24674
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/22/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon leak occurred.The target lesion was located in a vein.A 6x80x135mm mustang balloon catheter was advanced for dilation.However, during inflation at 15cc, it was observed that the pressure went down to 5 cc.The device was removed and the balloon was found leaking.The procedure was completed with a different device.No patient complications were reported and the patients status was stable.
 
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Brand Name
MUSTANG
Common Device Name
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7973671
Report Number2134265-2018-61966
Device Sequence Number1774407
Product Code FGE
UDI-Device Identifier08714729793793
UDI-Public08714729793793
Combination Product (Y/N)N
Initial Reporter CountryID
PMA/510(K) Number
K141521
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/17/2018
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
Operator of Device Health Professional
Device Expiration Date02/14/2021
Device Model Number24674
Device Catalogue Number24674
Device Lot Number0021749040
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/24/2018
Initial Report FDA Received Date10/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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