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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 12/26/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years of age or older.(b)(6).
 
Event or Problem Description
It was reported that balloon rupture occured.The target lesion was located in the common iliac artery (cia).A 8.0 x 20 mustang balloon catheter was advance for dilation.However, balloon ruptured at below rated burst pressure.The procedure was completed with a different device successfully.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 Key8339603
Report Number2134265-2019-01288
Device Sequence Number16632909
Product Code FGE
UDI-Device Identifier08714729793519
UDI-Public08714729793519
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) 02/14/2019
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 Date08/01/2021
Device Model Number24674
Device Catalogue Number24674
Device Lot Number0022458841
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/21/2019
Initial Report FDA Received Date02/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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