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

Model Number	H74939347080470
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by manufacturer: the athletis device was returned for analysis.A visual examination identified that the balloon was not folded which is an indication that the balloon had been subjected to positive pressure.The balloon was inflated and a pinhole leak was noted 4mm distal of the distal markerband.The recommended introducer/guide sheath size for this device as per specification is minimum 6fr.The sheath used by the customer was not returned for analysis.The investigator was unable to insert the device through the introducer sheath, as was unable to apply a vacuum due to the pinhole leak.A visual and tactile examination found no kinks or damage to the shaft and tip of the device.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 10jul2025.It was reported that the device was unable to cross the sheath.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified brachiocephalic vein.A 8.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilation.However, the device was unable to cross the 6f non-boston scientific sheath.The procedure was completed with another of the same device.There was no patient complications noted as a result of this event.However, returned device analysis revealed a pinhole leak was noted 4mm distal of the distal 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: 22704301
• Report Number: 2124215-2025-46338
• Device Sequence Number: 9035768
• Product Code: LIT
• UDI-Device Identifier: 08714729974055
• UDI-Public: (01)08714729974055(17)280317(10)36092922
• 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
• Report Date (Section B): 08/04/2025

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: H74939347080470
• Device Catalogue Number: H74939347080470
• Device Lot Number: 0036092922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: TERUMO 6F.
• Patient Sex: Unknown