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

Model Number	24634
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was difficult to remove from the sheath and damaged the sheath.The 80-90% stenosed target lesion was located in the mildly tortuous and non-calcified arteriovenous graft stenosis.An 8.00mm/2.0cm/135cm peripheral cutting balloon was used.During the first inflation at 10 atmospheres, the balloon ruptured.Prior to removal, the balloon was fully deflated, however, the balloon was difficult to remove from the sheath and slicing it open.A surgical cutdown was done to remove the device from the patient.Another 6.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.The balloon was inflated to 10 atmospheres.Prior to removal, the balloon was fully deflated, however, the balloon was difficult to remove from the sheath and slicing it open.The balloon and the sheath were removed safely.A new sheath was inserted so closure could be secured.There were no patient complications as a result of 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: 24767752
• Report Number: 2124215-2026-18220
• Device Sequence Number: 10267942
• Product Code: PNO
• UDI-Device Identifier: 08714729813729
• UDI-Public: (01)08714729813729(17)271104(10)37869619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/08/2026

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: 0037869619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 11/04/2025
• 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
• Patient Sex: Unknown