MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Athletis?; catheter, angioplasty, peripheral, transluminal

Model Number	H74939347070470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the cephalic vein of the forearm.A 7.0 mm x 40 mm x 75 cm athletis balloon catheter was advanced to the lesion site for dilatation.After the balloon was positioned, inflation was initiated.When the inflation pressure reached 26 atmospheres, further pressure increase was not possible.The balloon catheter was withdrawn and upon reinflation, the balloon was observed to have ruptured.The device was removed and the procedure was completed with another of same device.No patient injury was reported as a result of this event.The patient condition following procedure was stable.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as adverse event related to patient anatomy and / or condition.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 50201430
• Report Number: 2124215-2026-42732
• Device Sequence Number: 5521184
• Product Code: LIT
• UDI-Device Identifier: 08714729973911
• UDI-Public: (01)08714729973911(17)280430(10)36420425
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: H74939347070470
• Device Catalogue Number: H74939347070470
• Device Lot Number: 0036420425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 05/01/2025
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 94 LB