MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VORTX - 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 82865

Device Problems Contamination (1120); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2019

Event Type  malfunction  

Event Description

It was reported that the device became unsterile.A 3mm/2.5 mm vortx - 18 was selected for use.During preparation, it was noted that the mount was missing, and the package was opened with force.Consequently, the device bounced out of the package and became unsterile.There was no anomaly with the pouch prior to use and has never been opened.The procedure was completed with another of the same device.No patient involvement.

• Brand Name: VORTX - 18
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9575405
• MDR Text Key: 178006732
• Report Number: 2134265-2019-16657
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729324843
• UDI-Public: 08714729324843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0023911327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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