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

Model Number G08357

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2017

Event Type  malfunction  

Event Description

As the cook tornado embolization coil was removed from the package it was bent and deemed unusable by interventional radiology staff.A second tornado coil was opened to complete the procedure.The device will be returned to the manufacturer for failure analysis.

• 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: 6496940
• MDR Text Key: 72892376
• Report Number: 6496940
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G08357
• Device Catalogue Number: MWCE-18S-4/2-TORNADO
• Device Lot Number: 7425121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 93 YR
• Patient Weight: 68