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

Model Number	24628
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.An 8.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the balloon would not inflate.The balloon was removed and upon trying to inflate, a leak and a tiny hole was noted in the balloon.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from a balloon pinhole located approximately 1mm proximal of the distal markerband.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.An 8.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the balloon would not inflate.The balloon was removed and upon trying to inflate, a leak and a tiny hole was noted in the balloon.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 18230711
• Report Number: 2124215-2023-66038
• Device Sequence Number: 5341817
• Product Code: PNO
• UDI-Device Identifier: 08714729813798
• UDI-Public: 08714729813798
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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: 01/25/2025
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0030926309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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