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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

(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 there was an incident involving a retracta detachable embolization coil during a splenic embolization of an unknown patient.When turning to detach the coil, the delivery wire separated.The separated piece of delivery wire could not be removed and remained in the patient.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome 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 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 Description

Per additional information received on 27mar2023, the catheter was flushed before each coil deployment.The coil was not retrieved.

Manufacturer Narrative

Investigation ¿ evaluation: a representative from ausl bologna ospedale maggiore (italy) reported that on 20mar2023, a retracta detachable embolization coil (rpn: mwcer-35-7-8; lot#: 14507470) delivery wire separated.The device was required for a splenic vessel embolization procedure.A 4 french cobra catheter from another manufacturer was flushed prior to coil deployment.During coil deployment, the delivery wire was rotated to detach the coil; however, the wire separated and was retained in the patient with the coil.No other adverse effects were reported for this incident.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 examination could be conducted.However, medical imaging was provided by the facility that showed the reported failure.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 device history record (dhr) for lot 14507470 found no nonconformances that could have contributed to the reported failure.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The current instructions for use [t_mwcer_rev5] state the following: "instructions for use.6.Under fluoroscopic visualization, slowly advance the delivery wire until the entire length of the coil exits the distal end of the catheter.Ensure that the junction remains positioned just inside the catheter tip.(fig.5) 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 gathered from a review of the dmr, ifu and dhr suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, a review of imaging provided by the facility, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiency.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: 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: 16614218
• MDR Text Key: 312011338
• Report Number: 1820334-2023-00312
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341897
• UDI-Public: (01)10827002341897(17)270223(10)14507470
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-7-8
• Device Lot Number: 14507470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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
• Treatment: COBRA 4FR. TERUMO CATHETER.
• Patient Outcome(s): Other