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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 24672
Medical Device Problem Codes Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/28/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture and detachment occurred.A 8.0 x 120, 75cm mustang balloon catheter was used for dilatation.However, the balloon ruptured and shredded apart in the patient's body.The detached fragment was completely removed from the patient's body.No patient complications were 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 Key9083911
Report Number2134265-2019-11288
Device Sequence Number2883221
Product Code FGE
UDI-Device Identifier08714729794431
UDI-Public08714729794431
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K103751
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/07/2022
Device Model Number24672
Device Catalogue Number24672
Device Lot Number0023756997
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/29/2019
Initial Report FDA Received Date09/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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