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

Model Number	H74939207100470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the right subclavian and brachiocephalic veins.A 10.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.During the procedure, the balloon was ruptured at 8 atmospheres.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection of the device revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 40mm distal of the proximal balloon sleeve.The distal section of balloon material had been pulled distally over the tip of the device.The rated burst pressure for this device is 14 atmospheres.A visual and tactile examination found the shaft of the device to be stretched between the proximal and distal markerbands.A separation of the shaft was also noted located approximately 22mm distal of the strain relief.The shaft separation displayed evidence of having been cut by a sharp implement.A visual examination found no issues with the markerbands of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the right subclavian and brachiocephalic veins.A 10.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.During the procedure, the balloon was ruptured at 8 atmospheres.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 21123785
• Report Number: 2124215-2024-83407
• Device Sequence Number: 12941308
• Product Code: LIT
• UDI-Device Identifier: 08714729809517
• UDI-Public: 08714729809517
• 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
• Report Date (Section B): 02/12/2025

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: H74939207100470
• Device Catalogue Number: H74939207100470
• Device Lot Number: 0033274801
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 64 KG