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

Model Number	24634
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon broke occurred.The target lesion was located in the peripheral artery.An 8.00mm/2.0cm/135cm 2cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the part of the balloon was broken.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the pcb was returned for analysis.A visual and tactile examination identified a shaft kink/shaft damage approximately 145mm proximal from the distal tip.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.No issues were noted with the balloon material.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.
Event or Problem Description
It was reported that balloon broke occurred.The target lesion was located in the peripheral artery.An 8.00mm/2.0cm/135cm 2cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the part of the balloon was broken.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon broke occurred.The target lesion was located in the peripheral artery.An 8.00mm/2.0cm/135cm 2cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the part of the balloon was broken.There were no patient complications as a result of this event.It was further reported that the mild tortuous was located the artery.The device was removed using snaring and the procedure was completed using different ballon plain old balloon angioplasty (poba).
Additional Manufacturer Narrative
B1 - adverse event/product problem: updated.B5 - describe event or problem: updated.Device evaluated by mfr: the pcb was returned for analysis.A visual and tactile examination identified a shaft kink/shaft damage approximately 145mm proximal from the distal tip.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.No issues were noted with the balloon material.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.
Event or Problem Description
It was reported that balloon broke occurred.The target lesion was located in the peripheral artery.An 8.00mm/2.0cm/135cm 2cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the part of the balloon was broken.There were no patient complications as a result of this event.It was further reported that the mild tortuous was located the artery.The device was removed using snaring and the procedure was completed using different ballon plain old balloon angioplasty (poba).It was further reported that the device was broken into two pieces.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.Device evaluated by mfr: the pcb was returned for analysis.A visual and tactile examination identified a shaft kink/shaft damage approximately 145mm proximal from the distal tip.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.No issues were noted with the balloon material.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23977286
• Report Number: 2124215-2026-00667
• Device Sequence Number: 4630003
• Product Code: PNO
• UDI-Device Identifier: 08714729813781
• UDI-Public: (01)08714729813781
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0036068643
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 01/29/2026; 02/18/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/05/2026; 02/26/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown