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	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and non-calcified abdominal aorta.A 33/7/2/65 equalizer balloon catheter was advanced for dilation.However, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications nor injuries were reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Visual inspection revealed the balloon was ruptured.Under microscope it was confirmed the ruptured of the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and non-calcified abdominal aorta.A 33/7/2/65 equalizer balloon catheter was advanced for dilation.However, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications nor injuries were reported, and the patient was in good condition after the procedure.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15525647
• Report Number: 2124215-2022-38783
• Device Sequence Number: 6078824
• Product Code: MJN
• UDI-Device Identifier: 08714729402398
• UDI-Public: 08714729402398
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: 12/05/2022
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0027608577
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 11/13/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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