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

Model Number	H74939347100470
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the 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 identified a balloon pinhole located approximately 3mm distal of the proximal markerband.As per specification, the rated burst pressure for this device is 30 atmospheres.The balloon could not be inflated due to the pinhole in the balloon material.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2025.It was reported that the balloon was leaking contrast and did not inflate.The stenosed target lesion was located in the arteriovenous fistula.A 10.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilation.However, while dilating the balloon with the inflator, it was confirmed that the contrast agent was leaking.As a result, the balloon did not expand and was deemed defective.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a balloon pinhole located approximately 3mm distal of the proximal markerband.

• 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: 22056624
• Report Number: 2124215-2025-31746
• Device Sequence Number: 7156846
• Product Code: LIT
• UDI-Device Identifier: 08714729974215
• UDI-Public: (01)08714729974215(17)270517(10)34055048
• 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
• Report Date (Section B): 05/20/2025

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: 0034055048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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 Sex: Unknown