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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 05/13/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous vessel in the upper limb.A 6.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.However, during the first inflation at 24 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of the 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 Key10076773
Report Number2134265-2020-06810
Device Sequence Number2848833
Product Code FGE
UDI-Device Identifier08714729793397
UDI-Public08714729793397
Combination Product (Y/N)N
Initial Reporter CountryJA
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) 05/20/2020
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 Date08/15/2021
Device Model Number24674
Device Catalogue Number24674
Device Lot Number0022524066
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/13/2020
Initial Report FDA Received Date05/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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