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

Model Number	24628
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation issue occurred, requiring the use of a needle to deflate it.An 8.00mm/2.0cm/50cm peripheral cutting balloon was advanced for dilation.During the procedure, the balloon was inflated to less than 10 atmospheres; however, the balloon would not deflate during the attempt to deflate it.Multiple attempts were made, but the attempts were unsuccessful.The physician had to place a small needle through the patient's skin to puncture the balloon in the patient's arm.A fistula was being treated in the arm and the vessel is really superficial so placing a needle is a very easy process to get to the balloon.It took 5 minutes to deflate the balloon.The balloon was fully deflated and removed intact, and the procedure was completed with this device.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22588608
• Report Number: 2124215-2025-48331
• Device Sequence Number: 9052356
• Product Code: PNO
• UDI-Device Identifier: 08714729813798
• UDI-Public: (01)08714729813798(17)261030(10)35180772
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 07/24/2025

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: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0035180772
• 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: 06/27/2025
• Initial Report FDA Received Date: 07/24/2025
• Date Device Manufactured: 10/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown