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

Model Number	24686
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured, and partially sheared off the shaft.Fortunately, it stayed to the shaft but there was resistance coming out of the sheath.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.
Additional Manufacturer Narrative
Date of event date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured, and partially sheared off the shaft.Fortunately, it stayed to the shaft but there was resistance coming out of the sheath.No patient complications were reported.It was further reported that the target lesion was located someplace in the arm.
Event or Problem Description
It was reported that balloon rupture occurred.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured, and partially sheared off the shaft.Fortunately, it stayed to the shaft but there was resistance coming out of the sheath.No patient complications were reported.It was further reported that the target lesion was located someplace in the arm.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: a risk review performed for the (product name) device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Risk review: a risk review performed for the gladiator device confirmed that the event of balloon - material rupture and balloon - difficult to remove/withdraw from sheath were a known events defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific concludes the most probable root cause as adverse event related to procedure.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 18069612
• Report Number: 2124215-2023-61233
• Device Sequence Number: 18084909
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: 08714729809876
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 04/09/2026

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 Model Number: 24686
• Device Catalogue Number: 24686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 03/25/2026
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/23/2023; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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