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

Event Date 12/15/2022

Event Type  Injury  

Event Description

It was reported that a retracta detachable embolization coil was difficult to deploy and did not detach from the delivery wire."the wire broke before the detach system".Additional information regarding the event and patient outcome has been requested but is currently unavailable.

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 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.

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 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

In additional information, it was reported the device was required for a pelvic vein embolization procedure.During coil deployment, the detachment system stayed inside the catheter.The delivery wire broke inside the catheter, and a fragment of the wire was retained in the vein.The surgeon then "impacted" the fragment with more coils.No other adverse effects were reported for this incident.

Event Description

Per additional information received 13jan2023, at least 25/30 anticlockwise rotations were performed during deployment of the device.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5 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, 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported by the clinique tivoli (france) that on 15dec2022 the delivery wire of a retracta detachable embolization coil (rpn: mwcer-35-7-10; lot#: 14336768) separated.The device was required for a pelvic vein embolization procedure.During the procedure, the vascular surgeon used several retracta coils.When the surgeon attempted to detach the complaint device, difficulty was experienced.The delivery wire was rotated at least 25-30 times in a counterclockwise fashion while within the catheter; however, the coil would not detach.Eventually, the delivery wire separated and was retained in the patient¿s vein.The surgeon then impacted the fragment of the delivery wire with additional coils.No other adverse effects were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures for the device, as well as a visual inspection of a customer provided image, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a photo was received from the customer on 30jan2023 showing the clinical imaging and a description stating, "the delivery wire broke and a part of it stayed attached to the coil".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 14336768 records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook reviewed product labeling.The current instructions for use [t_mwcer_rev5] state the following: "precautions: prior to introduction of the embolization coil, flush the angiographic catheter with saline.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.Note: advancing the delivery wire slowly allows the junction to be seen more easily and reduces the risk of damaging it.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 or 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 indicates the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, inspection of the customer provided image, 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 was not properly aligned just inside of the catheter, 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.

• 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: 16017027
• MDR Text Key: 308453013
• Report Number: 1820334-2022-01871
• Device Sequence Number: 1
• Product Code: KRD
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2023

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-35-7-10
• Device Lot Number: 14336768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/20/2022; 01/13/2023; 03/06/2023
• Supplement Dates FDA Received: 12/27/2022; 01/16/2023; 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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: HNBR5.0-35-100-P-NS-MPA; COOK SHEATH: KCFW-5.0-18/38-90-RB-ANL0-HC
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female