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

Model Number	27775
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in internal iliac artery/hypogastric artery.An ob/6-6/2/80 occlusion balloon catheter was selected for use.During the procedure, the balloon threaded into the guidewire and upon inflation, the occlusion balloon burst, and the contrast came to the artery circulation.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in internal iliac artery/hypogastric artery.An ob/6-6/2/80 occlusion balloon catheter was selected for use.During the procedure, the balloon threaded into the guidewire and upon inflation, the occlusion balloon burst, and the contrast came to the artery circulation.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
The device was not returned.However, a photo was provided from the healthcare facility.It was observed the rupture reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in internal iliac artery/hypogastric artery.An ob/6-6/2/80 occlusion balloon catheter was selected for use.During the procedure, the balloon threaded into the guidewire and upon inflation, the occlusion balloon burst, and the contrast came to the artery circulation.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual and media inspection revealed that it is possible to observe that the balloon was rupture.No other issues were identified during the product analysis.

• 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: 20013744
• Report Number: 2124215-2024-51304
• Device Sequence Number: 4325217
• Product Code: MJN
• UDI-Device Identifier: 08714729112495
• UDI-Public: 08714729112495
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2024

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: 04/21/2025
• Device Model Number: 27775
• Device Catalogue Number: 27775
• Device Lot Number: 0032890129
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 11/13/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/24/2024; 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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 Age: 40 YR
• Patient Sex: Male