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

Model Number N/A

Device Problems Retraction Problem (1536); Difficult or Delayed Separation (4044)

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

Event Date 12/28/2023

Event Type  malfunction  

Event Description

It was reported that difficulty was experienced when attempting to deploy a retracta detachable embolization coil into an unknown patient during a varicocele embolization procedure.Upon opening the package, no damage to the device was noted.During the procedure, the physician experienced difficulty when attempting to detach the retracta coil from the delivery wire.The coil was repositioned approximately two to three times and a total of ten counterclockwise rotations were made to release the coil; however, these attempts were unsuccessful.As the physician began to remove the wire and coil from the 5fr catheter, more difficulty was experienced.As a result, the catheter, wire and coil were all removed from the patient together as a unit.A visual examination found no damage to the junction zone of the delivery wire and coil.It was confirmed that the physician flushed the catheter prior to each coil deployment.The procedure was able to be completed successfully, as embolization had already been achieved before the retracta was to be placed.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.The patient was not on any anticoagulation medication at the time of the procedure.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): postal code: (b)(6).E3 - occupation: lead nurse.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 or unavailable.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 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 and a photo were provided on 08jan2024.The junctional zone was just outside the catheter when the clinician tried to detach it.A photo was provided that was just before the clinician advanced the coil out of the catheter to try and deploy/detach it.Counter clockwise rotations were made to try and detach the coil.This was attempted numerous times.In the end, the coil itself was getting twisted.The clinician decided that it was safer to retrieve the entire coil rather than risk it becoming stuck or be deployed in the wrong place.The clinician was not able to retract the coil completely back into the catheter and had to remove the catheter and coil together completely.

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, unavailable, or unchanged.Investigation/evaluation: one used device was received for evaluation on 17apr2024.Upon a visual inspection, it was noted that the coil was kinked 0.5 cm from the end.Elongation was noted on the delivery wire; however, it was possible that this damage was sustained during the returned shipping process.There were no changes made to the investigation conclusions based on the updated device failure analysis.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

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 unknown, unavailable, or unchanged.Correction: h6 - annex a and annex g investigation ¿ evaluation it was reported that difficulty was experienced when attempting to deploy a retracta detachable embolization coil into an unknown patient during a varicocele embolization procedure.During the procedure, the physician experienced difficulty when attempting to detach the retracta coil from the delivery wire.The coil was repositioned approximately two to three times and a total of ten counterclockwise rotations were made to release the coil; however, these attempts were unsuccessful.As the physician began to remove the wire and coil from the 5fr catheter, more difficulty was experienced.As a result, the catheter, wire and coil were all removed from the patient together as a unit.A visual examination found no damage to the junction zone of the delivery wire and coil.It was confirmed that the physician flushed the catheter prior to each coil deployment.The procedure was able to be completed successfully, as embolization had already been achieved before the retracta was to be placed.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.The patient was not on any anticoagulation medication at the time of the procedure.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, cook received one device in a sealed and unopened condition from the customer.The returned device was deployed via the loading cannula without any issue.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 dhrs for the reported complaint device lot and the related subassembly lots revealed no relevant non-conformances.A complaint history search for complaints on the reported lot found no additional complaints reported from the field.Cook also reviewed product labeling.The ifu [t_mwcer_rev6] packaged with the device contains the following in relation 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." the information provided upon review of the device master record, instructions for use, and the device history record 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 unused, unopened 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 was stated the user had the junction zone of the delivery wire just outside of the catheter, as opposed to just inside as stated in the instructions for use, and this possibly led to this failure, but that could not 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: 18459885
• MDR Text Key: 332736635
• Report Number: 1820334-2024-00030
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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-35-14-10
• Device Lot Number: 14975530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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: 5FR COBRA CATHETER; COOK RPN: MWCE-35-20-10; GEL FOAM