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

Model Number	H74939207060440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon damaged occurred.The patient was presented with artificial arteriovenous fistula stenosis of left upper limb.A 6.0 x40, 40cm gladiator balloon catheter was advanced for dilation.There was no damage on the outer packaging.During first inflation at 18 atmospheres, it was noted that the pressure decreases.The balloon was removed from the patient's body.When checked, it was noted that the balloon was damaged.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient was stable post procedure.
Event or Problem Description
It was reported that balloon damage occurred.The patient was presented with artificial arteriovenous fistula stenosis of left upper limb.A 6.0 x40, 40cm gladiator balloon catheter was advanced for dilation.There was no damage on the outer packaging.During first inflation at 18 atmospheres, it was noted that the pressure decreases.The balloon was removed from the patient's body.When checked, it was noted that the balloon was damaged.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient was stable post procedure.It was further reported that the target lesion was 85% stenosed, moderately tortuous and moderately calcified.
Additional Manufacturer Narrative
Device evaluated by mfr: the gladiator elite was returned for analysis.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out and the balloon was inflated to its rated burst pressure for 30 seconds using deionized water and digital timer without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per hub the rated burst pressure for this device is 24 atmospheres.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft and no damage to the tip.
Event or Problem Description
It was reported that balloon damage occurred.The patient was presented with artificial arteriovenous fistula stenosis of left upper limb.A 6.0 x40, 40cm gladiator balloon catheter was advanced for dilation.There was no damage on the outer packaging.During first inflation at 18 atmospheres, it was noted that the pressure decreases.The balloon was removed from the patient's body.When checked, it was noted that the balloon was damaged.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient was stable post procedure.It was further reported that the target lesion was 85% stenosed, moderately tortuous and moderately calcified.It was confirmed that the balloon burst.

• 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: 22004516
• Report Number: 2124215-2025-29426
• Device Sequence Number: 9099761
• Product Code: LIT
• UDI-Device Identifier: 08714729809722
• UDI-Public: (01)08714729809722(17)250927(10)30234648
• 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): 06/30/2025

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: 09/27/2025
• Device Model Number: H74939207060440
• Device Catalogue Number: H74939207060440
• Device Lot Number: 0030234648
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 06/06/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/05/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 60 KG