MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	24634
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a balloon rupture occurred.The target lesion, exhibiting 100% stenosis, was located in a moderately tortuous and moderately calcified peripheral artery, involving in-stent restenosis within previously placed stents in the p1 and p2 segments of the popliteal artery, with additional distal disease.The affected segment was pre-dilated using a 5.0 x 120 mm sterling balloon inflated to nominal pressure.It was noted that the stent in the p2 segment was undersized, resulting in a flow-limiting narrowing.A 5.0 mm x 20 mm x 135 cm otw peripheral cutting balloon was advanced over a v18 guidewire to treat the lesion.During inflation at 10 atmospheres for approximately 10 seconds within the p2 segment, balloon rupture occurred.The device was removed without complication.A second 6.0 mm x 20 mm otw peripheral cutting balloon was subsequently advanced to the same segment and inflated to 10 atmospheres; balloon rupture again occurred during inflation.The device was removed without resistance.Following these events, a 5.0 x 40 mm x 135 cm charger balloon was advanced and inflated to 20 atmospheres.Thereafter, a 5.0 x 150 mm x 150 cm ranger device was used to treat the diseased vessel.The procedure was successfully completed using alternative devices.There were no patient complications associated with this event.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• 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: 24896881
• Report Number: 2124215-2026-20606
• Device Sequence Number: 8805948
• Product Code: PNO
• UDI-Device Identifier: 08714729813699
• UDI-Public: (01)08714729813699(17)270918(10)37485153
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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 Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0037485153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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: GUIDEWIRE: V18.
• Patient Sex: Unknown