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	08/16/2022
Type of Reportable Event	Malfunction
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 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
It was reported that a nester platinum embolization microcoil became lodged in the catheter during a type 2 endoleak repair.The anatomical target was an aortic aneurysm and the vessel was approximately 7 cm.The user attempted to deploy the coil using a competitor's catheter and the wire guide and flush technique but the coil lodged in the catheter.The catheter and and coil were then removed with about half a centimeter of coil exiting the distal tip of the catheter.An additional wire alongside the coil was observed, which prevented the coil from advancing.A new, like coil and catheter were used to successfully complete the procedure.It was noted that a coil from the same lot had been placed successfully prior to the failure and that the catheter was flushed before each coil deployment.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, unavailable, or unchanged.Investigation ¿ evaluation umass med ctr: university campus (united states) informed cook on (b)(6) 2022 of an event that occurred on the same date involving an mwce-35-14-10-nester-01 (nester platinum embolization microcoil) from lot 14271068.It was reported that the coil would not advance from the loading cartridge and there was an additional wire found in the loading cartridge that was preventing advancement.There were no adverse effects reported to the patient due to this occurrence.Reviews of 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, a coil and a wire, were returned.Length of the wire was 19.7cm and the outer diameter was 0.00922.Cook has concluded that the device was manufactured out of 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 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 no additional nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The current instructions for use [t_nec2_rev0] does not have wording about this specific failure.Based on the information provided, inspection of the returned device, and the results of the investigation, cook confirmed this device was sent with the production process's working stylet.Therefore cook has concluded this event is due to a manufacturing deficiency.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.
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: 15292270
• Report Number: 1820334-2022-01398
• Device Sequence Number: 7167192
• Product Code: KRD
• UDI-Device Identifier: 00827002473454
• UDI-Public: (01)00827002473454(17)261022(10)14271068
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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 Model Number: N/A
• Device Catalogue Number: MWCE-35-14-10-NESTER-01
• Device Lot Number: 14271068
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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: ANGIODYNAMICS, 5FR X 100 CM (.035 OR .038); WIRE GUIDE (MANUFACTURER UNKNOWN)
• Patient Sex: Male