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

Model Number N/A

Device Problems Material Separation (1562); Difficult or Delayed Separation (4044)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: purchasing.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 the delivery wire of a retracta detachable embolization coil separated during a gonadal embolization procedure on a 63-year-old female patient.As the physician rotated the delivery wire to release the retracta coil, it was found that the coil would not detach from the wire.The wire was rotated further and then separated, leaving a small portion of the wire attached to the coil in the patient's gonadal vein.The separated portion of the wire was unable to be retrieved from the patient.Additional information regarding event details has been requested but is currently unavailable.Another instance of wire separation during the same procedure is captured in a report with patient identifier: (b)(6).

Event Description

In additional information received on 15may2023, it was confirmed that the gonadal vein was the target location for the coil.A torque device was used during deployment.It was noted that the coil junction was not within the tip of the catheter while deploying.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6- annex f.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

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

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation.A representative of (b)(4) (colombia) reported that on 22apr2023 the delivery wire from a retracta detachable embolization coil (rpn: (b)(4); lot#: 15204818) separated.The device was required for a gonadal embolization procedure in a female patient with pelvic varices.During the procedure, the delivery wire was rotated multiple times to deploy the coil; however, the coil did not release from the wire.The delivery wire was rotated further and separated.A portion of the wire attached to the coil was retained in the patient.Additional communication with the customer confirmed the torque device was used during deployment.The customer also noted that the coil junction was not within the tip of the catheter during deployment.No other adverse events were reported due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu) of the complaint device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 15204818 and the related subassembly lots revealed no relevant non-conformances.No additional complaints were found with the reported lot number.Cook also reviewed product labeling.The ifu, [t_mwcer_rev6], packaged 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, instructions for use, and the 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, no product returned, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The customer stated the junction zone was not within the tip of the catheter at the time of deployment, so it is possible that failure to follow the instructions for use contributed to this event, but this was not 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.

• 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: 16914528
• MDR Text Key: 315068158
• Report Number: 1820334-2023-00587
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002342047
• UDI-Public: (01)10827002342047(17)280202(10)15204818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2023

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-35-14-20
• Device Lot Number: 15204818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/15/2023; 10/09/2023; 10/16/2023
• Supplement Dates FDA Received: 05/18/2023; 10/10/2023; 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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: COOK CATHETER: HNB5.0-38-100-P-NS-MPA; MWCER-35-14-20, LOT: 15207543
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female