MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

Model Number	M001173010
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon popped during inflation.The target lesion was located in a non-tortuous and non-calcified hepatic vein.An occlusion balloon catheter was advanced for dilation.However, the balloon popped during first inflation at 2 atmospheres for less than 10 seconds.The device was successfully removed from the patient without any fragments left.Additionally, multiple kinks were noted with the shaft.The procedure was completed with another occlusion balloon.There was no patient complications noted as a result of this event.
Event or Problem Description
It was reported that balloon popped during inflation.The target lesion was located in a non-tortuous and non-calcified hepatic vein.An occlusion balloon catheter was advanced for dilation.However, the balloon popped during first inflation at 2 atmospheres for less than 10 seconds.The device was successfully removed from the patient without any fragments left.Additionally, multiple kinks were noted with the shaft.The procedure was completed with another occlusion balloon.There was no patient complications noted as a result of this event.
Additional Manufacturer Narrative
The device was not returned for analysis.However, an investigation was concluded with the attached picture provided.Media inspection observed that the device was kinked.

• Brand Name: OCCLUSION BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21916831
• Report Number: 2124215-2025-26718
• Device Sequence Number: 8714880
• Product Code: MJN
• UDI-Device Identifier: 08714729112495
• UDI-Public: (01)08714729112495(17)260624(10)35683016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132990
• 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): 06/05/2025

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: 06/24/2026
• Device Model Number: M001173010
• Device Catalogue Number: M001173010
• Device Lot Number: 0035683016
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/05/2025
• Date Device Manufactured: 01/22/2025
• 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