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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 Problems Material Puncture/Hole (1504); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2019
Event Type  malfunction  
Event Description
It was reported that balloon pinhole occured.The target lesion was located in a fistula.A 12.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.The balloon was inflated at nominal pressure; however, a pinhole was noted on the balloon.There were no patent complications reported.
 
Manufacturer Narrative
H6 device code corrected from 1504 material puncture/hole to 1546 material rupture.
 
Event Description
It was reported that balloon pinhole occurred.The target lesion was located in a fistula.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.The balloon was inflated at nominal pressure; however, a pinhole was noted on the balloon.There were no patent complications reported.It was further reported that the procedure was completed with another balloon and the patient's status was fine.
 
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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
MDR Report Key9014680
MDR Text Key158098660
Report Number2134265-2019-11168
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K132810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24686
Device Catalogue Number24686
Was Device Available for Evaluation? No
Date Manufacturer Received09/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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