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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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2021
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 6.0 x20, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during second inflation at 24 atmospheres, the balloon ruptured.The procedure was completed with the original device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
Device evaluated by mfr: a gladiator 6 x 20,24atm,75cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 32mm in length and extended from a position 6mm proximal of the proximal markerband to 5mm distal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture occurred.A 6.0 x20, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during second inflation at 24 atmospheres, the balloon ruptured.The procedure was completed with the original device.There were no patient complications nor injuries 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
MDR Report Key11186926
MDR Text Key227504347
Report Number2134265-2021-00427
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729809715
UDI-Public08714729809715
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 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/23/2023
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0025628525
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2021
Date Manufacturer Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE USED: 180CM LAUREATE MERIT; GUIDEWIRE USED: 180CM LAUREATE MERIT; INFLATOR USED: MERIT PRESTO; INFLATOR USED: MERIT PRESTO; INTRODUCER SHEATH USED: 6FR BS SUPER SHEATH; INTRODUCER SHEATH USED: 6FR BS SUPER SHEATH
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