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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 Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2022
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the mildly tortuous fistula.A 035/180 starter guidewire was used to cross the lesion and a 10.0 x80, 75cm gladiator balloon catheter was advanced for dilatation.However, the wire seemed to shear and the balloon was stuck on itself.The balloon was not inflated at that point, it was just positioned and noticed it was stuck in the wire.The balloon shaft was also noted to be kinked.Both the balloon and guidewire were removed together as one unit.The procedure was completed with a different device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: a gladiator device was returned for analysis.Device was received with the customers guidewire inserted in the device.A visual examination of the returned device found that the balloon had not been inflated and was refolded.No issues were noted with the balloon material which may have potentially contributed to the complaint incident.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified a kink 380mm distal from the distal end of the strain relief and damage to the tip of the device.The investigator was unable to remove the guidewire from the device and was unable to insert a new boston scientific 0.035in (0.89 mm) guidewire due to the shaft kink and damage.
 
Event Description
It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the mildly tortuous fistula.A 035/180 starter guidewire was used to cross the lesion and a 10.0 x80, 75cm gladiator balloon catheter was advanced for dilatation.However, the wire seemed to shear and the balloon was stuck on itself.The balloon was not inflated at that point, it was just positioned and noticed it was stuck in the wire.The balloon shaft was also noted to be kinked.Both the balloon and guidewire were removed together as one unit.The procedure was completed with a different device.There were no patient complications 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
pmt 741 persiaran cassia selat
bandarcassia, pulau pinan 14110
MY   14110
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14395669
MDR Text Key291628624
Report Number2134265-2022-05458
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729826415
UDI-Public08714729826415
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0028411973
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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