MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Occlusion Balloon Catheter; Catheter, Percutaneous

Model Number	M001171030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2026.It was reported that balloon expansion issue occurred.The target lesion was a tight stenotic occlusion located in the iliac artery.A 7/2/100 occlusion balloon catheter was advanced for dilation.During the procedure, the balloon did not fully expand.The procedure was completed with a different device.There were no patient complications as a result of this event.However, device analysis revealed that the balloon ruptured.
Additional Manufacturer Narrative
Investigation results: device evaluated by mfr: the occlusion balloons device was returned to our post market quality assurance laboratory.Visual and microscopic inspection was performed and identified that the balloon has ruptured.This concludes the product analysis.Device history record (dhr) review: the device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50844007
• Report Number: 2124215-2026-50246
• Device Sequence Number: 21407840
• Product Code: MJN
• UDI-Device Identifier: 08714729112396
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 Expiration Date: 10/01/2026
• Device Model Number: M001171030
• Device Catalogue Number: M001171030
• Device Lot Number: 0036420197
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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 Age: 58 YR
• Patient Sex: Male