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

Model Number 39200

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2020

Event Type  malfunction  

Event 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
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9873794
• MDR Text Key: 184807769
• Report Number: 2134265-2020-03516
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805328
• UDI-Public: 08714729805328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024843616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1