MAUDE Adverse Event Report: COOK INC TORNADO PLATINUM EMBOLIZATION MICROCOIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Occupation: coordinator.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported foreign matter was found in the peel-away packaging for a tornado platinum embolization microcoil.The foreign matter was discovered at a third party distributor and did not reach a user facility.
Event or Problem Description
No additional information has been added to the description of event since the previous medwatch report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation evaluation.A review of the complaint history, instructions for use (ifu), device history record and quality control and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, cook completed a review of the device history record (dhr).The device history record for lot 9174942 found no non-conformances.Because there are no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Per the quality engineering risk assessment, no further action is required.The appropriate personnel were notified, and cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: TORNADO PLATINUM EMBOLIZATION MICROCOIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8143038
• Report Number: 1820334-2018-03488
• Device Sequence Number: 16616219
• Product Code: KRD
• UDI-Device Identifier: 00827002092150
• UDI-Public: (01)00827002092150(17)231011(10)9174942
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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
• Operator of Device: Other
• Device Expiration Date: 10/11/2023
• Device Model Number: N/A
• Device Catalogue Number: MWCE-18S-8/4-TORNADO
• Device Lot Number: 9174942
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1