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

Model Number	H74939347100470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 10.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilation.During the procedure, the balloon burst at 30 atmospheres.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.A 10.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilation.During the procedure, the balloon burst at 30 atmospheres.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D4: corrected lot number to 0034482623.Device evaluated by mfr: the athletis device was returned for analysis.Upon visual inspection, it was noted that the balloon was not folded, suggesting that the balloon had been exposed to positive pressure.The device has a rated burst pressure of 30 atmospheres.The returned device was connected to an encore inflation unit.During testing, positive pressure was applied, and leakage from a pinhole in the balloon was observed, located approximately 13mm distal to the proximal marker band.A thorough visual and tactile examination revealed no kinks or damage to the shaft.Additionally, no damage to the tip was identified through visual and tactile assessment.

• 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: 21831140
• Report Number: 2124215-2025-22061
• Device Sequence Number: 9500398
• Product Code: LIT
• UDI-Device Identifier: 08714729974215
• UDI-Public: (01)08714729974215(17)270722(10)34482623
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 06/04/2025

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: H74939347100470
• Device Catalogue Number: H74939347100470
• Device Lot Number: 0034482623
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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: 64 YR
• Patient Sex: Male