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

Model Number	H74939207050440
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon leak occurred.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, when the balloon was fully inflated, oozing blood flowed into the pressure pump.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the gladiator was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 24 atmospheres as per gladiator elite specification.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 5mm proximally of the proximal marker band.An examination of the balloon material and proximal marker band identified no issues.A visual and tactile examination was performed on the balloon material, tip, shaft, and markerband of the device and found no issues or damage.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that balloon leak occurred.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, when the balloon was fully inflated, oozing blood flowed into the pressure pump.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the gladiator was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 24 atmospheres as per gladiator elite specification.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 5mm proximally of the proximal marker band.An examination of the balloon material and proximal marker band identified no issues.A visual and tactile examination was performed on the balloon material, tip, shaft, and markerband of the device and found no issues or damage.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that balloon leak occurred.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, when the balloon was fully inflated, oozing blood flowed into the pressure pump.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that no pinhole was noted in the balloon.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20834041
• Report Number: 2124215-2024-75630
• Device Sequence Number: 14432752
• Product Code: LIT
• UDI-Device Identifier: 08714729809661
• UDI-Public: 08714729809661
• 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): 02/04/2025

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: H74939207050440
• Device Catalogue Number: H74939207050440
• Device Lot Number: 0032833323
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 01/06/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/27/2024; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 50 KG