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	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the main cephalic vein about 5 cm above the anastomosis of the left forearm arteriovenous fistula.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon third inflation at 18 to 20 atmospheres.The balloon was noted to be fractured in the middle.The device was removed, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).A4: weight: 65.5.Device evaluated by mfr: the gladiator was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A full balloon circumferential tear was identified located approximately 20mm proximal of the distal balloon markerband.The distal section of the balloon material had been pulled distally towards the tip of the device.This type of damage potentially occurred when the device was being withdrawn through the sheath.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of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.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the main cephalic vein about 5 cm above the anastomosis of the left forearm arteriovenous fistula.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon third inflation at 18 to 20 atmospheres.The balloon was noted to be fractured in the middle.The device was removed, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable.

• 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: 19996035
• Report Number: 2124215-2024-49339
• Device Sequence Number: 15204052
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• 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): 09/20/2024

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: 0032705580
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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: 52 YR
• Patient Sex: Male