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

Model Number	39347-051050
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the balloon ruptured.A 5.0mm x 100mm x 50cm athletis pta balloon dilatation catheter was selected for use in a shunt percutaneous transluminal angioplasty procedure (pta).The target lesion was 90% stenosed with moderate calcification and moderate tortuosity.When the device was inflated, it ruptured.A new device was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Additional product code (d2b): dqy.Report being sent to correct fields e1: initial reporter country, e2, e3.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient anatomy and/or condition.
Event or Problem Description
It was reported the balloon ruptured.A 5.0mm x 100mm x 50cm athletis pta balloon dilatation catheter was selected for use in a shunt percutaneous transluminal angioplasty procedure (pta).The target lesion was 90% stenosed with moderate calcification and moderate tortuosity.When the device was inflated, it ruptured.A new device was used to complete the procedure.There were no patient complications.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• 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 ; 7634941632
• MDR Report Key: 12748970
• Report Number: 2134265-2021-13605
• Device Sequence Number: 4471394
• Product Code: LIT
• UDI-Device Identifier: 08714729973720
• UDI-Public: 08714729973720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Expiration Date: 04/21/2024
• Device Model Number: 39347-051050
• Device Catalogue Number: 39347-051050
• Device Lot Number: 0027189540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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