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

Model Number	24686
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	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 30% stenosed target lesion was located in the upper limb vessel.A 0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, the balloon pressure did not reach the right pressure and the balloon was ruptured.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 30% stenosed target lesion was located in the upper limb vessel.A 0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, the balloon pressure did not reach the right pressure and the balloon was ruptured.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.It was further reported that the stenosed target lesion was located in the moderately tortuous and the balloon ruptured after the first inflation at 10 atmospheres.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr: the device 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 balloon longitudinal tear was identified beginning at the proximal markerband and extending distally across the balloon material to the distal markerband.The rated burst pressure for this device is 20 atmospheres.A visual examination identified damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The 30% stenosed target lesion was located in the upper limb vessel.A 0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, the balloon pressure did not reach the right pressure and the balloon was ruptured.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.It was further reported that the stenosed target lesion was located in the moderately tortuous and the balloon ruptured after the first inflation at 10 atmospheres.It was further reported that the correct size of the device is a 7.0 x40, 75cm gladiator elite balloon catheter.

• 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: 20235595
• Report Number: 2124215-2024-57523
• Device Sequence Number: 8089545
• 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,Followup
• Report Date (Section B): 11/04/2024

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: 0032512400
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 10/21/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/14/2024; 11/04/2024
• 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: Male