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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter city: (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 right superficial femoral artery.After a 6f non-bsc sheath was inserted and a non-bsc guidewire crossed the lesion, a 4.0 x 100, 75cm mustang balloon catheter was advanced for dilation.However, during first inflation at 10 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with a non-bsc 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 Key12038093
Report Number2134265-2021-07965
Device Sequence Number11751961
Product Code FGE
UDI-Device Identifier08714729794240
UDI-Public08714729794240
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K103751
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/21/2021
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 Date03/24/2023
Device Model Number24674
Device Catalogue Number24674
Device Lot Number0025397953
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/07/2021
Initial Report FDA Received Date06/21/2021
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
GUIDEWIRE: VASSALO FLOPPY; INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: 6F PARENT; MICRO CATHETER: PROMINENT STANDARD; STENT: FLUVIA6MM.12CM
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