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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 24673
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 6.0 x 200, 75cm mustang balloon catheter was advanced for dilatation.However, during third inflation at 16 atmospheres for 10 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
MUSTANG
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9390449
MDR Text Key174394021
Report Number2134265-2019-14586
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729794509
UDI-Public08714729794509
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 11/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24673
Device Catalogue Number24673
Device Lot Number0023031718
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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