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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 separated while advancing through a 100cm kmp catheter during a left side uterine vein embolization procedure on a female patient.The access site was reported to be in the right ij.Imaging provided by the customer showed a separated coil in the vessel of the patient.The physician believed the coil "sliced" while advancing through the catheter, due to left over embolization product used to close off the vessel that remained in the catheter.The separated coil did not migrate, as gel foam and one additional coil were successfully placed to mitigate the risk.The user reported that the catheter was flushed between each coil deployment.No further intervention was required.It was confirmed that the patient did not experience any adverse effects 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
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: vascular & intervention specialists oc (united states) informed cook on 16mar2023 of an event that occurred on the same date involving a nester platinum embolization microcoil (rpn: mwce-35-7-10-nester-01, lot: 13354362).It was reported that while deploying the coil through the catheter, it separated.It should be noted that the user stated they did not believe this was a product error, rather there was left "sclerotic" (an embolization product) in the catheter, that caused the coil to separate.The patient did not experience any adverse effects, and the procedure was completed with an additional coil and gel foam.Reviews of the complaint history, device history record (dhr), quality control procedures and instructions for use (ifu) of the device, 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 dhrs for the reported complaint device lot (13354362) revealed one possibly relevant non-conformance for separated coil; however, this step is checked 100% and all nonconforming products have been scrapped.A database 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_nec2_rev0] supplied with the device states the following in consideration of the reported failure mode: "how supplied upon removal from package, inspect the product to ensure no damage has occurred." based on the available information, no product returned, and the results of the investigation, cook has concluded this failure can be traced to an adverse event related to the procedure.It was reported that the physician believes the event was not due to a product error but was related to left over sclerotic (embolization product) in the catheter.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: 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: 16644135
• Report Number: 1820334-2023-00347
• Device Sequence Number: 17697849
• Product Code: KRD
• UDI-Device Identifier: 00827002473652
• UDI-Public: (01)00827002473652(17)250820(10)13354362
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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 Expiration Date: 08/20/2025
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-7-10-NESTER-01
• Device Lot Number: 13354362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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: 100CM KMP CATHETER.
• Patient Sex: Female