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	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arm vessel.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon inflation at 10 atmospheres.The procedure was completed with another of the same device.No complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).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 longitudinal tear was identified in the balloon material.The tear measured 7mm in length and extended from a position 3mm proximal of the distal markerband to 3mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination identified a shaft kink approximately 145mm distal from the distal end of the strain relief.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 arm vessel.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon inflation at 10 atmospheres.The procedure was completed with another of the same device.No complications were reported, and the patient status 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: 18376090
• Report Number: 2124215-2023-72803
• Device Sequence Number: 7617465
• Product Code: LIT
• UDI-Device Identifier: 08714729809722
• UDI-Public: 08714729809722
• 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): 01/31/2024

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: 09/13/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030144044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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: 50 YR
• Patient Sex: Unknown