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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 Codes Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 12/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event or Problem Description
It was reported that balloon rupture and device detachment occurred.The patient presented for a fistulogram.A 12.0 x 60, 75cm mustang balloon catheter was introduced.However, during inflation, the balloon ruptured and frayed.The device was removed but remnants were left inside the patient and the patient was sent to surgery.The procedure was not completed.No further 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 Key11004586
Report Number2134265-2020-17608
Device Sequence Number16361261
Product Code FGE
UDI-Device Identifier08714729794738
UDI-Public08714729794738
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K141521
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/14/2020
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 Date04/24/2023
Device Model Number24674
Device Catalogue Number24674
Device Lot Number0025467573
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/02/2020
Initial Report FDA Received Date12/14/2020
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 Required Intervention;
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