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

Catalog Number	MWCE-35-14-10-NESTER
Medical Device Problem Codes	Unraveled Material (1664); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nester platinum embolization coil unraveled.During the procedure, the coil was "mal-deployed" and protruded into the renal vein.When the coil was retrieved, it unraveled and elongated.A provided photo shows the reported failure.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 or unavailable.E1 - customer (person): postal code: (b)(6).E3 - occupation: radiology senior staff nurse g4 ¿ pma/510(k) #: preamendment 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
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.Correction: h6 - annex a.Investigation ¿ evaluation: a facility informed cook on 17nov2023 of an event that occurred on the same date involving an mwce-35-14-10-nester (nester platinum embolization coil).It was reported that the user had difficulty deploying the coil in the correct location, and it was protruding into the renal vein.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.Cook received one device in a used condition and five unused devices.Upon visual examination of the returned used device, it was found that there was approximately 5.5cm of undamaged coil, some elongation, and then approximately 1cm of additional undamaged coil.Upon opening the sealed pouches no visible damage was noted to the loading cannulas/cartridges.No damage was noted to any of the coils, and all the coils deployed without any issues.None of the coils were exiting out of the hub or distal tip prior to deployment.Cook has concluded that the devices were not 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 dhrs for the reported complaint device lot and the related subassembly lots revealed one related non-conformance in which all nonconforming product was scrapped.A complaint history 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 the field.Cook also reviewed product labeling.The ifu [t_ce_nec_rev4] supplied with the device states the following in consideration of the reported failure mode: "warnings: positioning of embolization coils should be done with particular care.Coils should not be left too close to the inlets of arteries and should be intermeshed with previously placed coils if possible.A minimal but sufficient arterial blood flow should remain to hold the coils against the previously placed coils until a solid clot ensure permanent fixation.The purpose of these suggestions is to minimize the possibility of loose coils becoming dislodged and obstructing a normal and essential arterial channel." based on the available information, no product returned, and the results of the investigation, a potential root cause has been traced to unintended use error.The ifu indicates that the coil should not be placed too close to the inlets of arteries and should be intermeshed with previously placed coils, if possible.It is possible that unintended use error contributed to the mal deployment; however, without additional info this cannot be definitely confirmed.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 toa death or serious injury if a malfunction occurred.

• 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: 18260908
• Report Number: 1820334-2023-01616
• Device Sequence Number: 14429493
• Product Code: KRD
• UDI-Device Identifier: 00827002269910
• UDI-Public: (01)00827002269910(17)280831(10)15636286
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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 Catalogue Number: MWCE-35-14-10-NESTER
• Device Lot Number: 15636286
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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
• Patient Age: 33 YR
• Patient Sex: Male