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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 Entrapment of Device (1212)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2020
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred. The 50-60% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery. A 6. 0 x 150, 135cm mustang balloon catheter was advanced for dilation. However, after deflation, the balloon refused to exit and became stuck over the wire. The device was removed with the whole system and completed the procedure with another of same device. There were no patient complications reported and the patient was stable.
 
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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 Key10793205
MDR Text Key214820724
Report Number2134265-2020-15180
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K103751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/07/2022
Device Model Number24672
Device Catalogue Number24672
Device Lot Number0023318269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
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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