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

Model Number	H74939207060470
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	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a forearm vessel.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, when the balloon was inflated to 20 atmospheres, the balloon ruptured and could not be expanded.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the gladiator elite 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 complete balloon circumferential tear was identified located approximately 25mm distal of the proximal markerband.As the distal section of balloon material had been pulled distal over the tip of the device.Inflation of the balloon is not possible.A visual and tactile examination found the shaft of the device to be severely stretched and kinked between the proximal and distal markerbands.A visual examination found no issues with the markerbands of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a forearm vessel.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, when the balloon was inflated to 20 atmospheres, the balloon ruptured and could not be expanded.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.It was further reported that the 60% stenosed target lesion was located in the mild tortuous and moderately vessel.The balloon ruptured upon first inflation for 30 seconds.The device was removed normally from the patient.

• 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: 20729464
• Report Number: 2124215-2024-72905
• Device Sequence Number: 12838259
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: 08714729809739
• 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): 12/10/2024

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: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0033536768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 56 KG