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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.The target lesion was located in the right saphenous vein.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during procedure at 14 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the right saphenous vein.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during procedure at 14 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.The balloon was inflated once and was removed completely from the patient's body.
 
Manufacturer Narrative
Device evaluated by mfr.: gladiator 12 x 40, 14atm, 75cm was returned or 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 61 mm in length and extended from a position 17 mm proximal of the proximal markerband to 13 mm 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.The target lesion was located in the right saphenous vein.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during procedure at 14 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.It was further reported that the target lesion was mildly tortuous and mildly calcified.The balloon was inflated once and was removed completely from the patient's body.
 
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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 Key11149286
MDR Text Key226118806
Report Number2134265-2021-00142
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,distri
Type of Report Initial,Followup,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2022
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024344013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight60
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