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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 12/10/2019
Event Type  Malfunction  
Event Description

It was reported that a balloon rupture occurred. Access was obtain via an ipsilateral approach. The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right superficial femoral artery. A 7. 0 x 150, 135cm mustang balloon catheter was advanced for dilation. However, during inflation at 10 atmospheres, the balloon ruptured. Another a 7. 0 x 150, 135cm mustang balloon catheter was advanced for dilation and also ruptured after being inflated to 10 atmosphere. The procedure was completed with another of the same device. There were no patient complications nor injuries 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 Key9482654
MDR Text Key176638390
Report Number2134265-2019-15882
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 02/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2019
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 Number0023314706
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 Manufactured02/08/2019
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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