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

Model Number	N/A
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	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter occupation: unknown.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
It was reported a male patient of unknown age required a nester platinum embolization microcoil for a variceal embolization procedure.During the procedure, the coil got stuck in the catheter.This was intended to be the last coil to be placed into the patient.The physician removed the device and decided to not place any more coils.The device was returned with the coil partially protruding from the distal tip and side port of the catheter.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.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
Additional information provided on 13jul2021 stated a bentson wire was used to deploy the coils through a 5 fr catheter.The catheter was not flushed after each coil.
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, unavailable, or unchanged.Investigation ¿ evaluation.(b)(6) radiology in the united states informed cook of an incident involving an mwce-35-14-8-nester-01 (nester platinum embolization microcoil) from lot 13023240.It was reported that after placing two coils successfully, the third coil got stuck in the catheter.The physician removed the device and decided not to place any more coils.There were no adverse effects to the patient recorded.The customer stated the user did not flush the catheter before each coil deployment.Reviews of documentation including the complaint history, device history record (dhr), quality control, and instructions for use (ifu), as well as a visual inspection of the returned device were conducted during the investigation.One used device was received.The coil appears to be exiting from the distal tip of the catheter and from a sideport that is 1.3cm from the distal tip.A hub was not present on the catheter.Cook has concluded that the device was manufactured to specification.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 (13023240) revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: "warnings nester embolization coils and microcoils are not recommended for use with polyurethane catheters or catheters with sideports.If a catheter with sideports is used, the embolus may lodge in the sideport or pass inadvertently through it.Precautions prior to introduction of the embolization coil, flush the angiographic catheter with saline.How supplied upon removal from package, inspect the product to ensure no damage has occurred." the instructions for use say it is not recommended to use a catheter with sideports, or the device may become lodged in a sideport.Also, the customer stated that they did not flush the catheter, which is specified as a step to effectively deploy this coil.Based on the available information, inspection of the returned device, and the results of the investigation, cook has concluded that failure to follow instructions is the cause of this occurrence.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 ; 8123392235
• MDR Report Key: 12150135
• Report Number: 1820334-2021-01747
• Device Sequence Number: 11966118
• Product Code: KRD
• UDI-Device Identifier: 00827002473553
• UDI-Public: (01)00827002473553(17)250316(10)13023240
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2022

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: 03/16/2025
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-14-8-NESTER-01
• Device Lot Number: 13023240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/13/2021; 02/17/2022
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 07/28/2021; 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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: 5FR C2 CATHETER; A "COUPLE" UNKNOWN COILS; COOK BENTSON WIRE
• Patient Sex: Male