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

Model Number	N/A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: lab manager.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 female patient required placement of a nester platinum embolization coil for coiling of a fistula near the brachial artery.After the coil was deployed in the patient, it was noted the coil did not curl and remained straight.The device was retrieved "via a small cutdown" with a clamp and hemostat.No additional coils were placed.It was noted that upon removal from the patient, the coil "looked more like a bow." no other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported by (b)(6) of (b)(6) in the united states that on (b)(6) 2021 a nester platinum embolization coil (rpn: mwce-35-14-12-nester; lot# 9246011) did not curl.The device was required for coiling of a fistula near the brachial artery.After the coil was deployed in the patient, it was noted the coil did not curl and remained straight.The device was retrieved "via a small cutdown" with a clamp and hemostat.No additional coils were placed.It was noted that when the coil was removed from the patient it still did not curl and ¿looked more like a bow¿.No other adverse effects were reported for this incident.Reviews of the complaint history, device history record (dhr), quality control, and instructions for use (ifu), as well as personnel interview 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 dhr for the reported complaint device lot (9246011) 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: "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 that component failure unrelated to manufacturing or design deficiencies contributed to this incident.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.
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 COIL
• 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: 11893384
• Report Number: 1820334-2021-01410
• Device Sequence Number: 14520056
• Product Code: KRD
• UDI-Device Identifier: 00827002269927
• UDI-Public: (01)00827002269927(17)231031(10)9246011
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-14-12-NESTER
• Device Lot Number: 9246011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female