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

Model Number	20280
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulties with deflation occurred.The stenosed target lesion was located in the mildly tortuous abdominal aorta.A 27/7/2/100 equalizer balloon catheter was advanced for dilatation.During the procedure, the balloon has difficulty deflating.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis and no damages were observed in the device returned.Under microscope no damages were observed.The functional test is performed, and it can be inflated and deflated the balloon normally.Based on the evidence, the as reported code ballon failure to deflate cannot be confirmed, since no damages were found during the product analysis and the balloon inflated and deflated normally.
Event or Problem Description
It was reported that difficulties with deflation occurred.The stenosed target lesion was located in the mildly tortuous abdominal aorta.A 27/7/2/100 equalizer balloon catheter was advanced for dilatation.During the procedure, the balloon has difficulty deflating.The procedure was completed with another of the same device.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: 20528085
• Report Number: 2124215-2024-65578
• Device Sequence Number: 7983697
• Product Code: MJN
• UDI-Device Identifier: 08714729402381
• UDI-Public: 08714729402381
• 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,Followup
• Report Date (Section B): 12/03/2024

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: 06/08/2025
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0033015910
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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 Sex: Unknown