MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939347060450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon pinhole was noted.A 6.0 mm x 40 mm x 50 cm athletis was advanced for dilation.However, despite pressurization up to 40 atmospheres, the stenosis could not be resolved.Consequently, a balloon pinhole was noted.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the athletis device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out and the balloon was inflated to its rated burst pressure of 40 atmospheres for 30 seconds using deionized water and digital timer, without any leaks or issues noted.A vacuum was then applied.The inflation device was verified at 40 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip of the device.Visual and tactile examination identified no issues with the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that a balloon pinhole was noted.A 6.0mm x 40mm x 50cm athletis was advanced for dilation.However, despite pressurization up to 40 atmospheres, the stenosis could not be resolved.Consequently, a balloon pinhole was noted.The procedure was completed with a different device.There were no patient complications as a result of this event.

• Brand Name: ATHLETIS?
• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23303894
• Report Number: 2124215-2025-73336
• Device Sequence Number: 21380671
• Product Code: LIT
• UDI-Device Identifier: 08714729973782
• UDI-Public: (01)08714729973782(17)280415(10)36310838
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201170
• 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): 11/17/2025

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: H74939347060450
• Device Catalogue Number: H74939347060450
• Device Lot Number: 0036310838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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