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

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient required placement of a nester platinum embolization microcoil for embolization of gastric varices using an echoendoscope.The coil was pushed through the introducer on the proximal end of an endoscopic ultrasound fine needle until it was fully inside the needle, and then the stylet needle was used to push the coil.However, the operator could not advance the coil into the patient.The physician removed the device and attempted again with another coil of the same lot.The same difficulty was experienced.The procedure was unable to be completed.The physician decided to continue watching the patient and may attempt to complete the procedure at a later date.At this time, there is no confirmation of a planned additional procedure.Images provided from the customer show both coils partially exited the tip of the needle.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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
Investigation ¿ evaluation: sutter cpmc van ness campus (united states) informed cook on 23mar2022 of an incident involving a patient requiring the placement of a nester platinum embolization microcoil (rpn: mwce-18-14-10-nester-01; lot: 14207549) for embolization of gastric varices using an echoendoscope.The coil was pushed through the introducer on the proximal end of an endoscopic ultrasound fine needle until it was fully inside the needle, and then the stylet needle was used to push the coil.However, the operator could not advance the coil into the patient.The physician removed the device and attempted again with another coil of the same lot.The same difficulty was experienced.The procedure was unable to be completed.The physician decided to continue watching the patient and may attempt to complete the procedure at a later date.At this time, there is no confirmation of a planned additional procedure.Images provided from the customer show both coils partially exited the tip of the needle.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), and instructions for use (ifu), as well as a visual inspection of the returned devices, were conducted during the investigation.The complaint devices were not returned; however, the customer did return seven unused, unopened devices from the same lot for evaluation.All seven devices returned were opened, and there was no trouble getting the coil to push out from the loading cartridge using the pusher stylet.The failure mode was unable to be confirmed.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 dhr for the reported complaint device lot 14207549 revealed no related non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.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] packaged with the device contains the following in relation to the reported failure mode: "instructions for use: for.018 inch microcoils: 1.Perform an angiogram prior to embolization to determine optimal catheter position.2.Push the loading cartridge completely into the delivery catheter.3.Advanced the luer lock connector fitting toward the catheter hub and lock into place.4.Use the pusher stylet to load the nestor embolization microcoil into the delivery catheter.Note: the stylet must be pushed as far as possible into the loading cartridge to ensure proper loading.Remove the pusher stylet and loading cartridge.5.To obtain secure placement of the nester embolization microcoil., we recommend the use of the pusher stylet to push the microcoil further into the delivery catheter.6.Once coil is positioned into delivery catheter, verify position of the catheter tip prior to deployment.Coil design permits delivery into the target vessel by saline/contrast flush or by push technique using an appropriately sized wire guide or pusher.7.Perform final angiogram to confirm coil position within target vessel." based on the information provided, inspection of the unused, unopened returned devices, and the results of the investigation, cook has determined that failure to follow instructions contributed to this failure due to the customer attempting to advance the coil through a needle and not a delivery 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, 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.

• 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 ; 8128294891
• MDR Report Key: 14110984
• Report Number: 1820334-2022-00569
• Device Sequence Number: 6229709
• Product Code: KRD
• UDI-Device Identifier: 00827002473256
• UDI-Public: (01)00827002473256(17)260926(10)14207549
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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: 09/26/2026
• Device Model Number: N/A
• Device Catalogue Number: MWCE-18-14-10-NESTER-01
• Device Lot Number: 14207549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2021
• 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: COOK ECHO-3-22
• Patient Sex: Unknown