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

Model Number	20280
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon deflation failure occurred.The stenosed target lesion was located in the abdominal aorta.A 33/7/2/100 equalizer balloon catheter was advanced for dilatation.During the procedure, the device experienced a deflation failure, making it difficult to remove.A non-bsc guidewire was deliberately used to rupture the balloon and facilitate its removal.The procedure was completed with another of the same device and there were no patient complications reported.

• 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: 20496740
• Report Number: 2124215-2024-65514
• Device Sequence Number: 19857706
• Product Code: MJN
• UDI-Device Identifier: 08714729402404
• UDI-Public: 08714729402404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2025
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0033860961
• 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: 09/25/2024
• Initial Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 04/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown