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

Model Number	H74939207070870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon was broken.The device was removed, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon was broken.The device was removed, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that the target lesion was 80-90% stenosed, moderately tortuous and severely calcified.The balloon was inflated 6-8 times and was ruptured during inflation at 30 atmospheres for 1 minute.
Additional Manufacturer Narrative
The device was returned for evaluation.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 95 mm in length and extended from a position 7 mm proximal of the proximal markerband to 14 mm distal of the distal markerband.A visual examination of the markerbands identified no issues.A visual and tactile examination identified multiple inner shaft kinks.A visual and tactile examination identified damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula.A 7.0 x80, 75 cm gladiator elite balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon was broken.The device was removed, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that the target lesion was 80-90% stenosed, moderately tortuous and severely calcified.The balloon was inflated 6-8 times and was ruptured during inflation at 30 atmospheres for 1 minute.

• 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 ; 6512422111
• MDR Report Key: 20926485
• Report Number: 2124215-2024-78968
• Device Sequence Number: 12025926
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: 08714729809838
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2025

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: 06/22/2025
• Device Model Number: H74939207070870
• Device Catalogue Number: H74939207070870
• Device Lot Number: 0029642600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 01/22/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/10/2025; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 65 KG