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

Model Number	82865
Medical Device Problem Codes	Contamination (1120); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9575405
• Report Number: 2134265-2019-16657
• Device Sequence Number: 3043008
• Product Code: KRD
• UDI-Device Identifier: 08714729324843
• UDI-Public: 08714729324843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102714
• 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): 01/10/2020

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: 05/06/2022
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0023911327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1