Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 24674
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/01/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 8.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.However, during the initial inflation at 10 atmospheres for 20 seconds, the balloon ruptured.The device was removed without any issue noted and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MUSTANG
Common Device Name
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10677041
Report Number2134265-2020-14170
Device Sequence Number2626939
Product Code FGE
UDI-Device Identifier08714729793519
UDI-Public08714729793519
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K141521
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/10/2023
Device Model Number24674
Device Catalogue Number24674
Device Lot Number0025696188
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/01/2020
Initial Report FDA Received Date10/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
GUIDEWIRE: RADIFOCUS; INTRODUCER SHEATH: 6FR SHORT; STENT: SMART
-
-