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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
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Event Description
It was reported the balloon burst circumferentially and detached. A 7. 0 x 150, 75cm mustang balloon was selected for use in a percutaneous transluminal angioplasty (pta) of the 90% stenosed, mildly tortuous and severely calcified superficial femoral artery (sfa). During the first inflation, the balloon burst circumferentially approximately 5cm from the tip. During removal, the distal portion broke off and was able to be removed from the patient still on the guidewire with out any complications. The procedure was completed with another device and no patient complications were reported.
 
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Brand NameMUSTANG
Type of DeviceCATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
pmt 741 persiaran cassia selat
bandarcassia, pulau pinan 14110
MY 14110
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12953475
MDR Text Key281918036
Report Number2134265-2021-15398
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K103751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24672
Device Catalogue Number24672
Device Lot Number0026069326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

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