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

Model Number	H74939207060470
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty and shaft break occurred.The patient was in chronic renal failure uremia hemodialysis state.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified artificial arteriovenous fistula of the left upper limb.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.The balloon was inflated to 20p, and the pressure was released.Subsequently, upon withdrawing the balloon, it was noted that the balloon and the shaft adhered and could not be withdrawn.Upon pulling, it was noted that the front end of the delivery shaft was fractured.The balloon was removed, and the procedure was completed.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that removal difficulty and shaft break occurred.The patient was in chronic renal failure uremia hemodialysis state.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified artificial arteriovenous fistula of the left upper limb.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.The balloon was inflated to 20p, and the pressure was released.Subsequently, upon withdrawing the balloon, it was noted that the balloon and the shaft adhered and could not be withdrawn.Upon pulling, it was noted that the front end of the delivery shaft was fractured.The balloon was removed, and the procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Correction to field d4: lot number from 0029458367 to 0032888257.Device evaluated by mfr: the gladiator? elite was returned for analysis.A visual and tactile examination identified a shaft separation located approximately 695mm distal of the strain relief.The distal section of the shaft including the distal section of balloon material both markerbands and tip was not returned for analysis.A visual examination identified a complete balloon circumferential tear located approximately 8mm distal of the proximal balloon bond.The distal section of balloon material was not returned for analysis.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: 22132873
• Report Number: 2124215-2025-33856
• Device Sequence Number: 8391785
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)250523(10)29458367
• 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): 07/14/2025

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: 0032888257
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 63 KG