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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 01/12/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0 x 20, 135cm mustang balloon catheter was advanced for dilatation.However, during initial inflation at 20 atmospheres, the balloon ruptured.The device was removed from the patient's body without problem and the procedure was completed with a different device.No patient complications were reported and the patient's status was good.
 
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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 Key11194484
Report Number2134265-2021-00453
Device Sequence Number17079953
Product Code FGE
UDI-Device Identifier08714729793724
UDI-Public08714729793724
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K103751
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) 01/19/2021
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 Date01/17/2021
Device Model Number24674
Device Catalogue Number24674
Device Lot Number0021626691
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/13/2021
Initial Report FDA Received Date01/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
INFLATION DEVICE USED (EVEREST)
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