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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC MUSTANG BALLOON

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BOSTON SCIENTIFIC MUSTANG BALLOON Back to Search Results
Model Number H74939171100470
Device Problems Material Rupture (1546); Defective Device (2588)
Patient Problem No Information (3190)
Event Date 08/03/2017
Event Type  Injury  
Event Description
Av fistula who underwent routine fistula reassessment and dedicated venoplasty on (b)(6) 2017 which was complicated by venoplasty balloon rupture, potentially related to a defective balloon. Specifically, balloon rupture occurred between 8-10 atm pressure, well below the related burst pressure of 16 atm. The dominant radiopaque balloon fragment that could be visualized fluoroscopically was successfully snared and removed prior to conclusion of the (b)(6) 2017 procedure. The remaining piece of the balloon was successfully removed by thoracic surgeon on (b)(6) 2017.
 
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Brand NameMUSTANG BALLOON
Type of DeviceMUSTANG BALLOON
Manufacturer (Section D)
BOSTON SCIENTIFIC
castle rock CO 80108
MDR Report Key6791397
MDR Text Key82690944
Report NumberMW5071540
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Model NumberH74939171100470
Device Lot Number20327135
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1
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