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

Model Number	H74939347080470
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty was encountered.Using a 7fr introducer, an 8.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.However, the balloon catheter became entrapped in the trochlear vessel during secondary entry.Another of same product was used on the patient without incident.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the athletis 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.Foreign material (fm) was identified wrapped around the center of the balloon.No other issues were found with the balloon.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination identified no damage to the tip of the device.
Event or Problem Description
It was reported that removal difficulty was encountered.Using a 7fr introducer, an 8.0mm x 40mm x 75cm athletis balloon catheter was advanced for dilatation.However, the balloon catheter became entrapped in the trochlear vessel during secondary entry.Another of same product was used on the patient without incident.No patient complications were reported.

• 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 ; 6128757234
• MDR Report Key: 20783302
• Report Number: 2124215-2024-74310
• Device Sequence Number: 17406423
• Product Code: LIT
• UDI-Device Identifier: 08714729974055
• UDI-Public: 08714729974055
• 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: Other Health Care Professional
• 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: H74939347080470
• Device Catalogue Number: H74939347080470
• Device Lot Number: 0033402283
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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