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	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon burst occurred.An equalizer balloon was selected for use.During the procedure, the balloon burst.The procedure was completed with another catheter.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned.Visual and microscopic inspection revealed that the balloon was ruptured.
Event or Problem Description
It was reported that a balloon burst occurred.An equalizer balloon was selected for use.During the procedure, the balloon burst.The procedure was completed with another catheter.There were no patient complications.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17144577
• Report Number: 2124215-2023-30072
• Device Sequence Number: 20228324
• Product Code: MJN
• UDI-Device Identifier: 08714729402411
• UDI-Public: 08714729402411
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: 03/29/2024
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0030441926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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