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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 08/20/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 5.0 x40, 40cm gladiator balloon catheter was advanced for dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
 
Event Description
It was reported that balloon rupture occurred.A 5.0 x40, 40cm gladiator balloon catheter was advanced for dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
 
Manufacturer Narrative
Device evaluated by mfr.:gladiator elite 5.0 x40, 40cm was returned for analysis.A visual examination identified that the balloon wings had been subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure and pressure held for 30 seconds without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use.This inflation to rate of burst pressure of 24 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination of the shaft of the device found no issues.A visual examination found no issues or damage to the markerbands of the device.No other issues were identified during the product 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 Key10475024
MDR Text Key205090474
Report Number2134265-2020-12021
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729809661
UDI-Public08714729809661
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 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/03/2022
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024710764
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Date Manufacturer Received10/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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