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	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 33/7/2/100 equalizer balloon catheter was advanced for dilatation.However, during first inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9448441
• Report Number: 2134265-2019-15418
• Device Sequence Number: 480396
• Product Code: MJN
• UDI-Device Identifier: 08714729402404
• UDI-Public: 08714729402404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1