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

Model Number	H74939207070870
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80-90% stenosed target lesion was located in the moderately tortuous and severely calcified arteriovenous fistula.A 7.0 x80,75cm gladiator elite balloon catheter was advanced for dilatation.During procedure, the balloon ruptured upon six or seven inflations at 20 atmospheres for one minute.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Device evaluated by mfr: the gladiator was returned for analysis.The device was received inserted in the customers introducer sheath, which was noted to be damaged.The investigator was able to remove the device from the introducer sheath as did not want to damage the device any further.A visual examination of the returned device found that the balloon had a full circumferential tear.The balloon was also noted to be pulled in a distal direction over the distal tip.The investigator was only able to view the distal markerband.No issues noted with the distal markerband.A visual and tactile examination identified multiple shaft kinks.A visual and tactile examination identified no damage to the tip.No other issues were identified with the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 80-90% stenosed target lesion was located in the moderately tortuous and severely calcified arteriovenous fistula.A 7.0 x80,75cm gladiator elite balloon catheter was advanced for dilatation.During procedure, the balloon ruptured upon sixth or seventh inflation at 20 atmospheres for one minute.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 80-90% stenosed target lesion was located in the moderately tortuous and severely calcified arteriovenous fistula.A 7.0 x80,75cm gladiator elite balloon catheter was advanced for dilatation.During procedure, the balloon ruptured upon sixth or seventh inflation at 20 atmospheres for one minute.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the gladiator was returned for analysis.The device was received inserted in the customers introducer sheath, which was noted to be damaged.The investigator was able to remove the device from the introducer sheath as did not want to damage the device any further.A visual examination of the returned device found that the balloon had a full circumferential tear.The balloon was also noted to be pulled in a distal direction over the distal tip.The investigator was only able to view the distal markerband.No issues noted with the distal markerband.A visual and tactile examination identified multiple shaft kinks.A visual and tactile examination identified no damage to the tip.No other issues were identified with the device.

• 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: 22669240
• Report Number: 2124215-2025-51536
• Device Sequence Number: 3702046
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: (01)08714729809838(17)250905(10)30088788
• 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): 11/20/2025

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: 09/05/2025
• Device Model Number: H74939207070870
• Device Catalogue Number: H74939207070870
• Device Lot Number: 0030088788
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 11/04/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/24/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 82 KG