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 Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left arm.A 8.0 x60, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation at 18 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Original bsc aware date : 12jul2019.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left arm.A 8.0 x60, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation at 18 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8831764
• Report Number: 2134265-2019-08787
• Device Sequence Number: 18909781
• Product Code: LIT
• UDI-Device Identifier: 08714729809890
• UDI-Public: 08714729809890
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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: 04/25/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023702665
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1