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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
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2019
Event Type  malfunction  
Event Description
It was reported that balloon pinhole occurred. The target lesion was located in an arteriovenous fistula. A 12. 0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation. However, the balloon would not inflate due to a small hole. The procedure was completed with a different device. No patient complications were reported and the patient was fine.
 
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Brand NameGLADIATOR ELITE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key9521618
MDR Text Key177134545
Report Number2134265-2019-16073
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729809555
UDI-Public08714729809555
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2022
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024485244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2019
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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