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	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Two 6.0 x80, 75cm gladiator balloon catheters were used on the same patient.The first balloon crossed the guidewire and entered the stenosis located in the arteriovenous graft of the left forearm.During the procedure, on the first inflation at 10 atmospheres, there was liquid leaking, a rupture occurred.The device was removed and replaced for the second gladiator balloon, but at 10 atmospheres, it was leaking liquid again.Another of the same model was used to continue the procedure and was pressurized at 22 atmospheres.The stenosis was dilated and the procedure was proceeded and ended successfully.No complications reported, and patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.Two 6.0 x80, 75cm gladiator balloon catheters were used on the same patient.The first balloon crossed the guidewire and entered the stenosis located in the arteriovenous graft of the left forearm.During the procedure, on the first inflation at 10 atmospheres, there was liquid leaking, a rupture occurred.The device was removed and replaced for the second gladiator balloon, but at 10 atmospheres, it was leaking liquid again.Another of the same model was used to continue the procedure and was pressurized at 22 atmospheres.The stenosis was dilated and the procedure was proceeded and ended successfully.No complications reported, and patient status was stable.It was further reported that the target lesion was located in the artificial blood vessel in the left forearm that was 75% stenosed, non-tortuous, and non-calcific.It was the first balloon that ruptured on the first inflation.The second balloon was simply leaking.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.The device was returned for analysis and the evaluation was completed on 24sep2024.A visual and tactile examination was performed, and a leak test identified balloon pinhole located approximately at the distal markerband.The tip was also damaged.There were no kinks or damage to the shaft, and markerbands were in the correct position of the device.

• 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: 20203448
• Report Number: 2124215-2024-57015
• Device Sequence Number: 6674517
• Product Code: LIT
• UDI-Device Identifier: 08714729809753
• UDI-Public: 08714729809753
• 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): 10/07/2024

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: 09/25/2026
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0032504236
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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