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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 Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/22/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in mildly tortuous and severely calcified popliteal artery.A 4.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.However, during second inflation at 24 atmospheres for 1 minute, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported.
 
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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 Key9682855
Report Number2134265-2020-01151
Device Sequence Number2800038
Product Code FGE
UDI-Device Identifier08714729793496
UDI-Public08714729793496
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
K103751
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/07/2020
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
Operator of Device Health Professional
Device Expiration Date04/21/2021
Device Model Number24674
Device Catalogue Number24674
Device Lot Number0022021770
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/22/2020
Initial Report FDA Received Date02/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age78 YR
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