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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 04/28/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - additional customer (person) information: postal code: (b)(6).Additional phone: (b)(6).E3 - occupation: cook uk sales representative.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

It was reported that the delivery wire for a cook retracta detachable embolization coil "snapped proximally to default zone".The product was eventually able to be deployed.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

Additional information was provided on 15may2023 and 16may2023.An ovarian embolization was being performed.A 5french catheter was being used in the procedure.The delivery wire was rotated counter clockwise as per instructions for use (ifu) to deploy to coil.The coil did not detach after 8-10 rotations and more rotations were attempted.Finally, the delivery wire snapped/broke proximal to the junction zone.The coil did not unravel.The junction portion of the delivery wire and the coil were left in the patient and have not been removed.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation it was reported by a representative at the (b)(6) clinic that on (b)(6) 2023 the delivery wire of a retracta detachable embolization coil (rpn: mwcer-35-14-18; lot#: 15166810) separated.The device was required for an ovarian embolization procedure.During the procedure, the delivery wire was rotated counterclockwise approximately 8-10 times, but the coil would not release.Additional rotations of the wire were performed, then the delivery wire separated prior to coil junction detachment.As a result, the coil and a portion of the delivery wire were retained in the patient.No other adverse effects were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.Cook received one partial device in a used condition.The delivery wire separated proximal to the junction zone.The inner wire was exposed on the returned portion of delivery wire.The coil was not returned.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 15166810 and related subassembly lots recorded no relevant non conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook also reviewed product labeling.The current instructions for use [t_mwcer_rev6] with the device contains the following in relation to the reported failure mode: "instructions for use 8.If the coil position is correct, use the torque device to turn the delivery wire counterclockwise 8-10 times, until coil detachment can be either felt of visualized under fluoroscopy.Note: it is recommended that the junction remain just inside the tip of the catheter." the information provided upon review of the dmr, dhr, and ifu 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, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible that the junction zone between the coil and delivery wire was outside of the catheter at the time of deployment, but this cannot be definitively 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 to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event 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: 16877135
• MDR Text Key: 314648298
• Report Number: 1820334-2023-00559
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002342030
• UDI-Public: (01)10827002342030(17)280116(10)15166810
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-18
• Device Lot Number: 15166810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/15/2023; 08/01/2023
• Supplement Dates FDA Received: 05/16/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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: CORDIS C2 5FRENCH CATHETER
• Patient Outcome(s): Disability
• Patient Sex: Female