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

Model Number	G26988
Medical Device Problem Codes	Separation Failure (2547); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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.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 embolization of an abdominal artery in a patient of unknown age and gender.The doctor used a pusher stylet to advance the coil into a microcatheter.Subsequently, a 0.016-inch guidewire was used to further push the coil to the target lesion.Resistance was encountered while advancing; however, the coil and wire were still able to advance.Following attempted deployment of the coil from microcatheter tip, the wire was withdrawn.It was found that the coil and wire were stuck together, resulting in removal of the entire device including microcatheter, guidewire and the coil from the patient.Alternative cook coils were used to complete the procedure, and they were functioning well.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.It was confirmed by the user that the catheter was flushed prior to each coil deployment.
Additional Manufacturer Narrative
Correction: h6 - annex a.Investigation ¿ evaluation: it was reported that a nester platinum embolization micro coil was difficult to deploy during an embolization of an abdominal artery in a patient of unknown age and gender.The doctor used a pusher stylet to advance the coil into a microcatheter.Subsequently, a 0.016-inch guidewire was used to further push the coil to the target lesion.Resistance was encountered while advancing; however, the coil and wire were still able to advance.Following attempted deployment of the coil from microcatheter tip, the wire was withdrawn.It was found that the coil and wire were stuck together, resulting in removal of the entire device including microcatheter, guidewire and the coil from the patient.Alternative cook coils were used to complete the procedure, and they were functioning well.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.It was confirmed by the user that the catheter was flushed prior to each coil deployment.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.Cook received one coil in a used condition.Upon visual inspection it was noted the received coil was already deployed, so tabletop testing of the device was unable to be performed.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 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the current instructions for use [t_ce_nec_rev4] includes table with information on recommended wire guide type and size, and it recommends using a 0.018in wire guide for coils with a diameter of 0.018in.Evidence gathered upon review of the dmr, ifu, dhr, and the returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.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.It is possible that using a wire guide that is smaller than recommended in the instructions for use led to this failure, but this could not be definitively confirmed.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor 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: 20523970
• Report Number: 1820334-2024-01398
• Device Sequence Number: 15483568
• Product Code: KRD
• UDI-Device Identifier: 00827002269880
• UDI-Public: (01)00827002269880(17)271108(10)15058238
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: G26988
• Device Catalogue Number: MWCE-18-14-4-NESTER
• Device Lot Number: 15058238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: ASAHI MEISTER 0.016 INCH WIRE; ASAHI PARKWAY SOFT (2.8FR-->1.98FR)
• Patient Sex: Unknown