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 GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
  • 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 GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24686
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/29/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the cephalic arc.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured almost fully effacing the lesion.The device was removed and the procedure was completed with another of same device.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GLADIATOR ELITE
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12281098
Report Number2134265-2021-10068
Device Sequence Number3611906
Product Code LIT
UDI-Device Identifier08714729809555
UDI-Public08714729809555
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K132810
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/05/2021
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 Date03/23/2024
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0027023033
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2021
Initial Report FDA Received Date08/05/2021
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
BALLOON INFLATOR: MERIT PRESTO; GUIDEWIRE: 180CM 0.035 COOK ROADRUNNER; INTRODUCER SHEATH: 7FR SUPER SHEATH BS
-
-