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	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the atrioventricular fistula brachial cephalic.A 8.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 20 atmospheres for 30 seconds.The device was removed, and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: used the procedure date provided as event date.
Additional Manufacturer Narrative
B3: date of event: used the procedure date provided as event date.Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the shaft was detached on 2 locations along the shaft.The first shaft detachment was located 2mm distal from the distal end of the strain relief.The second detachment was located 30mm distal from the proximal balloon bond.The inner shaft was noted to be accordioned.A visual examination of the balloon material identified a circumferential tear.The rated burst pressure for this device is 20 atmospheres.A visual examination observed no damage to the tip of the device.A visual examination found the markerbands to be detached from the shaft.The detached markerbands were not returned with the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the atrioventricular fistula brachial cephalic.An 8.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 20 atmospheres for 30 seconds.The device was removed, and the procedure was completed with a different device.No patient complications were reported.

• 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: 19669384
• Report Number: 2124215-2024-41150
• Device Sequence Number: 6851744
• Product Code: LIT
• UDI-Device Identifier: 08714729809913
• UDI-Public: 08714729809913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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 Expiration Date: 09/26/2026
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0032512406
• 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: 06/09/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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: Unknown