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	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.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 for 30 seconds using deionizes water and digital timer, without issue.A vacuum was then applied.The inflation device was verified at 20 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.As per specification the rated burst pressure for this device is 34 atmospheres.A visual examination found no issue with the tip, markerbands and shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial arteriovenous fistula.A 7.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilation.During the procedure, the balloon burst while blowing it inside the patient's body.The procedure was completed with another of the same device.No complications were reported, and the patient condition was stable.It was further reported that the stenosed target lesion was 75% and was mildly tortuous and mildly calcified.The balloon burst during second inflation at 16 to 20 atmospheres under 30 seconds.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial arteriovenous fistula.A 7.0mm x 40mm x 75cm athletics balloon catheter was advanced for dilation.During the procedure, the balloon burst while blowing it inside the patient's body.The procedure was completed with another of the same device.No complications were reported, and the patient condition was stable.

• 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 ; 6512422111
• MDR Report Key: 21171974
• Report Number: 2124215-2024-83071
• Device Sequence Number: 11825150
• Product Code: LIT
• UDI-Device Identifier: 08714729973911
• UDI-Public: 08714729973911
• 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): 02/13/2025

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: H74939347070470
• Device Catalogue Number: H74939347070470
• Device Lot Number: 0034215253
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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