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

Model Number	G26989
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	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nester platinum embolization microcoil was difficult to advance.The device was required for coiling of a pseudoaneurysm.The catheter was flushed prior to attempting to deploy the coil.The wire guide or flushing technique was used to deploy the coil.However, the coil was not able to be fully advanced out of the catheter and partially exited the distal tip of the catheter.As result, the procedure was completed by using another coil of the same size.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): mobile: (b)(6).G4 ¿ pma/510(k) #: preamendment.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.
Additional Manufacturer Narrative
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
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: annex a.Investigation ¿ evaluation.It was reported that a nester platinum embolization microcoil was difficult to advance.The device was required for coiling of a pseudoaneurysm.The catheter was flushed prior to attempting to deploy the coil.The wire guide or flushing technique was used to deploy the coil.However, the coil was not able to be fully advanced out of the catheter and partially exited the distal tip of the catheter.As result, the procedure was completed by using another coil of the same size.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instructions for use (ifu) for the device as well as a visual inspection of the returned device, were conducted during the investigation.One used loading cannula and pusher stylet were returned to cook for evaluation; the coil was not returned.Upon visual inspection, some damage was noted to the pusher stylet, however; no mention of damage to the pusher stylet was noted in the original complaint.Therefore, cook has concluded that this damage was most likely sustained during the returned shipping to cook.Additionally, 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 device history record (dhr) for the device lot found no relevant nonconformances.A review of related subassembly lots for coil component found two relevant nonconformance for separated coil and sharp weld, in which all the nonconforming products were scrapped.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 the field.Product labeling review: the current instructions for use [t_ce_nec_rev4] state the following: ¿precautions: perform an angiogram prior to embolization to determine correct catheter position.Prior to introduction of the embolization coil, flush the angiographic catheter with saline.¿ based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.Per the risk assessment no further action is required.The appropriate personnel have been notified.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: NESTER PLATINUM EMBOLIZATION MICROCOIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• 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: 21058787
• Report Number: 1820334-2025-00008
• Device Sequence Number: 15470788
• Product Code: KRD
• UDI-Device Identifier: 00827002269897
• UDI-Public: (01)00827002269897(17)290708(10)16141819
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2025

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: G26989
• Device Catalogue Number: MWCE-18-14-6-NESTER
• Device Lot Number: 16141819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 08/05/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/23/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: MICROWIRE.; PARKWAY MICROCATHETER 2.8FR-COMPANY-ASAHI.
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 68 KG