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

Model Number	24686
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left upper limb vessel.A 8.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.The stenosis was not removed when dilating the balloon under 20 atmospheres.During the second inflation, the balloon burst.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left upper limb vessel.A 8.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.The stenosis was not removed when dilating the balloon under 20 atmospheres.During the second inflation, the balloon burst.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.It was further reported that the target lesion was severely stenosed and that the balloon ruptured at 16 atmospheres.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left upper limb vessel.A 8.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.The stenosis was not removed when dilating the balloon under 20 atmospheres.During the second inflation, the balloon burst.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.It was further reported that the target lesion was severely stenosed and that the balloon ruptured at 16 atmospheres.
Additional Manufacturer Narrative
A gladiator device 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 57 mm in length and extended from a position 7 mm proximal of the proximal markerband to 6mm 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 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.This concludes the product analysis.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14588335
• Report Number: 2134265-2022-06352
• Device Sequence Number: 5517057
• Product Code: LIT
• UDI-Device Identifier: 08714729809869
• UDI-Public: 08714729809869
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2022

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: 04/15/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023654585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 06/07/2022; 07/14/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/14/2022; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2019
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 95 KG