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

Model Number	H74939207040470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 18mm proximal of the tip.The rated burst pressure for this device is 24 atmospheres as per specification.A visual examination identified damage to the tip.A visual examination found no damage or issues with the markerbands of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.No other issues were identified with the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and mildly calcified vena cephalica antebrachii.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During inflation at 19 atmospheres, the pressure could not continue to increase and the balloon burst.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and mildly calcified vena cephalica antebrachii.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During inflation at 19 atmospheres, the pressure could not continue to increase and the balloon burst.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21434931
• Report Number: 2124215-2025-10571
• Device Sequence Number: 4361291
• Product Code: LIT
• UDI-Device Identifier: 08714729809616
• UDI-Public: (01)08714729809616(17)270424(10)33890185
• 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): 04/02/2025

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: H74939207040470
• Device Catalogue Number: H74939207040470
• Device Lot Number: 0033890185
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 48 KG