MAUDE Adverse Event Report: COOK INCORPORATED TORNADO; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number G47417

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

A cook tornado embolization coil was opened and upon inspection the coil delivery system was bent prior to use.This was not used on a patient.

• Brand Name: TORNADO
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10337726
• MDR Text Key: 200795881
• Report Number: 10337726
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G47417
• Device Catalogue Number: MWCE-18S-4/2-TORNADO-01
• Device Lot Number: 10307340
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1