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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 Patient Involvement (2645)
Event Date 09/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that a balloon pinhole occurred.During preparation of two 10.0 x40, 75cm gladiator elite balloon catheters, it was noted that neither would inflate and that each had a hole in it.The procedure was completed with another size of the balloon.No patient complications were reported.
 
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Brand Name
GLADIATOR ELITE
Type of Device
CATHETER, 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 Key9169869
MDR Text Key161713810
Report Number2134265-2019-11938
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729809517
UDI-Public08714729809517
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 Other Health Care Professional
Type of Report Initial
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0023953516
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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