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

Model Number	G52731
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - phone number: (b)(6) g4 ¿ pma/510(k) #: preamendment h3 ¿ the device is not being returned for evaluation.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 nester platinum embolization microcoil was difficult to deploy during an unknown coil embolization procedure for an unknown patient.Resistance was felt within the catheter upon attempted advancement of the coil with the pusher.As a result, the coil became lodged within the catheter and was not able to be deployed as intended.Additional information was received 29jan2026, acknowledging that the coil exited the distal tip of the catheter, thus, prompting this report.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• Brand Name: NESTER 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: 24282835
• Report Number: 1820334-2026-00135
• Device Sequence Number: 13227167
• Product Code: KRD
• UDI-Device Identifier: 00827002527317
• UDI-Public: (01)00827002527317(17)300728(10)16712677
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: G52731
• Device Catalogue Number: MWCE-18-3-2-NESTER
• Device Lot Number: 16712677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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
• Patient Sex: Unknown