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

Model Number	G26994
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nester platinum embolization coil unraveled.Upon release of the nester coil during an unknown embolization procedure for an unknown patient, the coil "did not unwind completely and became frayed (apparently split lengthwise).In addition, several knots formed, particularly in the probe, where they remained stuck.The further the probe was withdrawn, the more the coil stretched." the device was exchanged for an unknown new device.The device was not retained in the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event has been requested but is currently unavailable.
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.
Additional Manufacturer Narrative
Additional information: b5, d10 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 in additional information received 25feb2026 that only one coil was involved.The coil was retrieved by changing the catheter.

• Brand Name: NESTER PLATINUM EMBOLIZATION COIL
• 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: 24427826
• Report Number: 1820334-2026-00210
• Device Sequence Number: 15981110
• Product Code: KRD
• UDI-Device Identifier: 00827002269941
• UDI-Public: (01)00827002269941(17)300527(10)16616976
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: G26994
• Device Catalogue Number: MWCE-35-14-6-NESTER
• Device Lot Number: 16616976
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 05/18/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 02/26/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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 5 FRENCH CATHETER.
• Patient Sex: Unknown