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

Model Number	G08261
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - phone number: (b)(6).G4 - pma/510(k) #: preamendment.H3 - device evaluated by mfg? the device will not be returned to the manufacturer.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 microcoil was inadvertently misplaced during a genicular artery embolization of the left knee for an 85-year-old female patient.One coil was placed in a branch of the genicular artery without incident.While attempting to place the second tornado coil in another branch, the wire was pushed through the end of the catheter.During withdrawal of the wire, the coil became attached to the wire and was withdrawn approximately 2-3cm into the main genicular artery.The surgeon pushed and pulled the wire few more times and the coil became unstuck; however, the coil deployed in a location higher than expected.It was confirmed that the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Additional information: d10 investigation ¿ evaluation it was reported that a tornado platinum embolization microcoil was inadvertently misplaced during a genicular artery embolization of the left knee for an 85-year-old female patient.During the procedure, an introducer was left in the catheter was used for deployment to achieve a greater length.One coil was placed in a branch of the genicular artery without incident.While attempting to place the second tornado coil in another branch, the wire was pushed through the end of the catheter.During withdrawal of the wire, the coil became attached to the wire and was withdrawn approximately 2-3cm into the main genicular artery.The surgeon pushed and pulled the wire few more times and the coil became unstuck; however, the coil deployed in a location higher than expected.It was confirmed that the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot and its related subassembly lots identified related discrepancies, and all discrepant product was scrapped.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu [t_ce_tem_rev3] supplied with the device states the following in consideration of the reported failure mode: ¿product recommendations wire guides recommended for positioning tornado embolization microcoils are tfe-coated.018inc (0.46mm) diameter with flexible tapered tips.¿ based on the available information, no product returned, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible that the user leaving an introducer in the catheter during deployment contributed to this failure; however, this possibility cannot be definitively confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.

• 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; bloomnington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23040266
• Report Number: 1820334-2025-01135
• Device Sequence Number: 9870849
• Product Code: KRD
• UDI-Device Identifier: 00827002082618
• UDI-Public: (01)00827002082618(17)281020(10)15717246
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 15717246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• 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: 2.7 FRENCH PROGREAT CATETER
• Patient Age: 85 YR
• Patient Sex: Female