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

Model Number	G08261
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - phone number: (b)(6).G4- pma/510(k) #: preamendment.H3: device evaluation anticipated, but not yet begun.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported that a tornado platinum embolization coil was difficult to advance and the coil migrated into a non-target artery.The patient was undergoing a coronary artery fistula embolization.During insertion and advancement of the coil through the microcatheter, excessive resistance was noted.The coil became stuck in the microcatheter and could not be advanced due to obstruction.While the coil was still inside the microcatheter, the connection between the push rod and the coil fractured.Before reaching the target vessel, unexpected premature deployment/extrusion of the coil from the distal tip of the catheter occurred during release manipulation and the coil migrated into the non-target patient artery.The coil became entangled with the vessel wall and was carried away by blood flow.The push rod was then withdrawn.The coil lost its embolic effect.A new device was opened to complete the procedure successfully.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• Brand Name: TORNADO PLATINUM EMBOLIZATION MICROCOIL
• Common Device Name: KRD; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 24766017
• Report Number: 1820334-2026-00357
• Device Sequence Number: 9299417
• Product Code: KRD
• UDI-Device Identifier: 00827002082618
• UDI-Public: (01)00827002082618(17)301001(10)16806235
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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 Model Number: G08261
• Device Catalogue Number: MWCE-18S-3/2-TORNADO
• Device Lot Number: 16806235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS 0.18 MICROCATHETER
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian