MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC

Model Number	39200
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination and balloon rupture occurred.A 6x60x120 epic vascular stent was selected for use.However, during preparation, the stent was contaminated by technologist.Another epic stent of an unknown size was successfully used.The target lesion was located in the iliac artery.After an unknown epic stent was deployed, a 8.0 x40, 135cm charger balloon catheter was advanced for dilatation.However, during inflation at nominal pressure, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9873794
• Report Number: 2134265-2020-03516
• Device Sequence Number: 16871506
• Product Code: NIO
• UDI-Device Identifier: 08714729805328
• UDI-Public: 08714729805328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 11/25/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024843616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1