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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 Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  Malfunction  
Event Description

It was reported that balloon rupture occurred. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right superior femoral artery. After crossing a v18 guide wire, a 7. 0 x 150, 75cm mustang catheter was advanced for pre-dilatation. However, during inflation at nominal pressure, the balloon ruptured. The device was replaced with another mustang balloon and the procedure was completed with a non-bsc stent. There were no patient complications 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
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9534750
MDR Text Key177152312
Report Number2134265-2019-16293
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK103751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24672
Device Catalogue Number24672
Device LOT Number0022460774
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/02/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/02/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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