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

Model Number	24686
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon ruptured occurred.The stenosed target lesion was in an arteriovenous fistula that was poorly functioning with a minimum diameter of 1.8 mm and a resistance index of 0.7 located in the left upper limb vessel.A 7.0 x40, 40cm gladiator elite was advanced over the guidewire for dilatation.However, during the inflation at 17 atmospheres, the balloon burst.The procedure was completed with another of same device and the stenosis was relieved.No patient complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 57 mm in length and extended from a position 10mm proximal of the proximal markerband to 8mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.A2 - age at time of event: 18 years or older.E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon ruptured occurred.The stenosed target lesion was in an arteriovenous fistula that was poorly functioning with a minimum diameter of 1.8 mm and a resistance index of 0.7 located in the left upper limb vessel.A 7.0 x40, 40cm gladiator elite was advanced over the guidewire for dilatation.However, during the inflation at 17 atmospheres, the balloon burst.The procedure was completed with another of same device and the stenosis was relieved.No patient complications were reported, and the patient status was stable.It was further reported that the target lesion was 70% stenosed, non-tortuous, and non-calcified.

• 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: 20564158
• Report Number: 2124215-2024-68024
• Device Sequence Number: 7532105
• Product Code: LIT
• UDI-Device Identifier: 08714729809784
• UDI-Public: 08714729809784
• 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): 11/19/2024

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: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0032593608
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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 Sex: Female