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

Model Number	H74939207060470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The patient underwent percutaneous ultrasound-guided balloon angioplasty of the left forearm arteriovenous fistula under regional block anesthesia.The 70% stenosed target lesion was located in a moderately tortuous and mildly calcified vessel.A 6.0 x 40 mm, 75 cm gladiator balloon catheter was advanced for dilatation.The balloon was inflated three times: first at 18 atm for 30 seconds, second at 20 atm for 30 seconds, and third at 24 atm, during which the balloon ruptured.The balloon rupture was detected while inflating the catheter using a pressure pump after it had been properly positioned in the vessel.The physician immediately removed the catheter and, together with the scrub and circulating nurses, inspected the device, finding the balloon ruptured into two segments with clean, smooth edges.The head nurse was promptly notified.An ultrasound examination of the treated vessel confirmed that no foreign material remained inside.The two ruptured segments were brought together by bending the catheter, and the ends matched perfectly, confirming that no fragments were missing.The procedure was completed using a different device without difficulty.No patient complications occurred as a result of the event, and the patient returned to the ward in stable condition.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23543159
• Report Number: 2124215-2025-82608
• Device Sequence Number: 18571733
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)280325(10)36153687
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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 Model Number: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0036153687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/13/2025
• Date Device Manufactured: 03/26/2025
• 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: 57 YR
• Patient Sex: Male