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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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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 Consequences Or Impact To Patient (2199)
Date of Event 01/23/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.A 10.0 x80, 75cm gladiator balloon catheter was selected for use.The balloon was took out from the package for preparation.However, a pinhole was noted as when the solution was put through the device, it all sprayed out.The procedure was completed with another of the same device.No patient complications were reported.
 
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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 Key9690351
Report Number2134265-2020-01229
Device Sequence Number2396325
Product Code LIT
UDI-Device Identifier08714729826415
UDI-Public08714729826415
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K132810
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/10/2020
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 Date09/23/2022
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024485247
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/23/2020
Initial Report FDA Received Date02/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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