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

Model Number	20280
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two equalizer balloons ruptured during aortic stent placement.An equalizer occlusion balloon catheter was chosen to assist with treatment for percutaneous aorto-bi-iliac stenting of an abdominal aortic aneurysm.An arteriography was performed to locate the renal arteries, and the stent was gradually deployed.The stent deployment was completed from the right side to the external iliac since the right hypogastric was occluded.During deployment of the aortic stent, the equalizer balloon ruptured.Another equalizer balloon was used; however, that balloon also ruptured.There were no patient complications or additional intervention necessary.

• Brand Name: EQUALIZER
• 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: 18639337
• Report Number: 2124215-2024-04692
• Device Sequence Number: 8092865
• Product Code: MJN
• UDI-Device Identifier: 08714729402398
• UDI-Public: 08714729402398
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140273
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2024

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: 02/19/2025
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0032261130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown