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

Model Number N/A

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

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 Description

It was reported a 91 year old female patient required a nester platinum embolization microcoil for repair of an endoleak from the lumbar artery.After successfully deploying two other coils, the third coil became lodged at the distal end of the catheter.The user tried to deploy it by flushing with saline and also utilizing another wire.Because they could not advance it further, the user decided to pull the catheter with the coil 3/4 of the way out.When they pulled the catheter right towards the groin, the coil dislodged and migrated to the perineal, where it now remains occluding that vessel.The procedure was concluded at this point, because it was found the patient had sufficient flow in the affected leg via two other patent vessels.As reported, the patient did not experience any other adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) (united states) informed cook on 15jun2022 of an event that occurred on the same date involving a nester platinum embolization microcoil (rpn: mwce-18-5-2-nester-01, lot: 14641662).It was reported that when pushing the coil through a.035¿ catheter, the coil only partially deployed.Next, the user attempted remove the catheter, the coil dislodged and advanced to an unintended location of the body.No harm to the patient has been reported at this time.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are currently in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14641662 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the product lot number.Cook also reviewed product labeling.The current instructions for use [t_nec2_rev0] state the following: "precautions if using a.018 inch nester embolization microcoil, ensure that the delivery catheter has an internal diameter (id) of.018 to.025 inch." evidence gathered upon review of the dmr, product labeling, and dhr, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product and the results of our investigation, it was concluded that an unintended user error contributed to the reported event.The coil was attempted to be advanced through an incorrectly sized catheter, leading to difficult release and deployment to an unintended location.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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 Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: NESTER PLATINUM EMBOLIZATION MICROCOIL
• Type of Device: 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: 14878774
• MDR Text Key: 303272002
• Report Number: 1820334-2022-01140
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00827002473331
• UDI-Public: (01)00827002473331(17)270502(10)14641662
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCE-18-5-2-NESTER-01
• Device Lot Number: 14641662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: .035 BERNSTEIN MERIT CATHETER; .035 TERUMO GLIDE WIRE
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Sex: Female