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

Model Number 82875

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the device became unsterile.A 4mm/3.7mm vortx diamond - 18 was selected for use.During preparation, the device became unsterile/filthy because it jumped out and was dropped while the nurse is handing the device to the doctor; device became unusable.There was a tendency that it jumped out when the device was taken out after there is no more mount/pasteboard.The procedure was completed with another of same device.No patient complications reported.

• Brand Name: VORTX DIAMOND - 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; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8249511
• MDR Text Key: 133111234
• Report Number: 2134265-2018-65094
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729324881
• UDI-Public: 08714729324881
• 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: 01/15/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2021
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0022386119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• 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