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

Model Number	20280
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon failed to deflate and became stuck in the endoprosthesis.Two 40x100 equalizer balloons were selected for a procedure in the aortic endoprosthesis.During the procedure, it was observed that the balloons were not folded upon themselves.Rather, they seemed opened and inflated.When removing the balloons, they became stuck within the upper hooks of the endoprosthesis.There were no patient complications reported.
Event or Problem Description
It was reported that the balloon failed to deflate and became stuck in the endoprosthesis.Two 40x100 equalizer balloons were selected for a procedure in the aortic endoprosthesis.During the procedure, it was observed that the balloons were not folded upon themselves.Rather, they seemed opened and inflated.When removing the balloons, they became stuck within the upper hooks of the endoprosthesis.There were no patient complications reported.It was further reported the balloon had scrubbed the mesh of the stent which was damaged.The balloon was removed and another equalizer balloon was used.The procedure was completed with a new intervention a month later.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7915534
• Report Number: 2134265-2018-61349
• Device Sequence Number: 19046701
• Product Code: MJN
• UDI-Device Identifier: 08714729402428
• UDI-Public: 08714729402428
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/24/2018

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: 06/19/2019
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0021621804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR