MAUDE Adverse Event Report: COOK INC RETRACTA DETACHABLE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number N/A

Device Problems Separation Failure (2547); Difficult or Delayed Separation (4044)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - customer (person): phone: (b)(6).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 that a retracta detachable embolization coil was difficult to deploy during a aaa procedure on an unknown patient.The physician rotated the torquer of the device many times, but the coil would not detach from the delivery wire.The entire system was removed from the patient and a pushable coil was used to complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding event details has been requested but is currently unavailable.

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

In additional information received on 30aug2023, it was confirmed that the junction zone was halfway inside and halfway outside of the catheter during deployment.A counterclockwise rotation was made by the user.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex a investigation ¿ evaluation it was reported that the embolization coil could not be deployed despite many turns of the torquer on 14aug2023.The device was removed and replaced to complete the procedure.Communication with the user facility confirmed that rotations were counterclockwise, and that the junction zone was halfway inside and halfway outside of the catheter when deploying.The patient reportedly experienced no adverse effects as a result of this incident.Reviews of the documentation, including the complaint history, device history record, drawing, instructions for use (ifu) and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One device without the coil was returned to the manufacturer for evaluation.The wire became lodged in the cannula during table-top testing.The complaint failure could not be replicated, as the coil was not returned.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that there are sufficient inspection activities in place to identify this failure mode prior to distribution.A review of the device history record (dhr) found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook was able to review product labeling.The product ifu, [t_mwcer_rev5] ¿retracta detachable embolization coils,¿ provides the following information to the user related to the reported failure mode: "under fluoroscopic visualization, slowly advance the delivery wire until the entire length of coil exits the distal end of the catheter.Ensure that the junction remains positioned just inside the catheter tip.Note: advancing the delivery wire slowly allows the junction to be seen more easily and reduces the risk of damaging it.Note: if significant resistance is encountered during coil advancement, do not continue advancing.Retract the delivery wire slightly, then gently re-advance it.If there is still significant resistance, withdraw the delivery wire from the catheter and try using a new coil with a shorter length." evidence provided by the complaint facility, device failure analysis, dhr, complaint history, and manufacturing documents, suggest that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure contributed to the reported event.A cause for the component failure cannot be established but the investigation suggests that the device was manufactured to specification.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.

• Brand Name: RETRACTA DETACHABLE EMBOLIZATION COIL
• 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: 17573209
• MDR Text Key: 321531168
• Report Number: 1820334-2023-01107
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002342047
• UDI-Public: (01)10827002342047(17)270823(10)14914335
• Combination Product (y/n): N
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• 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: MWCER-35-14-20
• Device Lot Number: 14914335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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