MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24686
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: GLADIATOR ELITE
• Common Device Name: 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 Key: 14395669
• Report Number: 2134265-2022-05458
• Device Sequence Number: 1970428
• Product Code: LIT
• UDI-Device Identifier: 08714729826415
• UDI-Public: 08714729826415
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0028411973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown