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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 12/03/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the second inflation to 10atms the balloon ruptured.A second 12x40 gladiator elite balloon was pulled to treat the distal part of the stent lesion and when inflated to 10atms, the balloon ruptured.The procedure was completed with another of the same device.No harm was caused to the patient.
 
Event Description
It was reported that balloon rupture occurred.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the second inflation to 10atms the balloon ruptured.A second 12x40 gladiator elite balloon was pulled to treat the distal part of the stent lesion and when inflated to 10atms, the balloon ruptured.The procedure was completed with another of the same device.No harm was caused to the patient.
 
Manufacturer Narrative
Device evaluated by mfr.: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 1mm distal of the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination found no issues with the tip or markerbands that could potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were noted with the device during analysis.
 
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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 Key9459520
MDR Text Key176382304
Report Number2134265-2019-15655
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729809555
UDI-Public08714729809555
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 02/19/2020
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
Device Operator Health Professional
Device Expiration Date08/21/2022
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024310328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received12/12/2019
Supplement Dates Manufacturer Received01/28/2020
Supplement Dates FDA Received02/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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