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 Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 33/7/2/100 equalizer balloon was selected for use for an aortic endovascular aneurysm repair (evar) procedure with mild tortuosity.During the procedure, the balloon ruptured when slight pressure was applied with a syringe.The device was removed from the patient with no issues.A second 33/7/2/100 equalizer balloon was used, but the same issue occurred.The procedure was successfully completed with a third equalizer balloon.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 33/7/2/100 equalizer balloon was selected for use for an aortic endovascular aneurysm repair (evar) procedure with mild tortuosity.During the procedure, the balloon ruptured when slight pressure was applied with a syringe.The device was removed from the patient with no issues.A second 33/7/2/100 equalizer balloon was used, but the same issue occurred.The procedure was successfully completed with a third equalizer balloon.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: device returned in its original box labeled with the correct batch number.The balloon was inspected and it was found burst.The device did not have visual defects.No more damage was found in the device.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9848338
• Report Number: 2134265-2020-03462
• Device Sequence Number: 16749327
• Product Code: MJN
• UDI-Device Identifier: 08714729402404
• UDI-Public: 08714729402404
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K140273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 12/02/2020
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0024054162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1