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

Model Number	G34200
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery wire included in retracta detachable embolization coil unraveled during a coil embolization procedure for endovascular aneurysm repair (evar) in a patient of unknown age and gender.The customer noted that there was no damage to the device upon opening the package.A pusher stylet was utilized for coil deployment and was advanced through the shipping cartridge without difficulty.The coil was introduced via a tortuous internal iliac artery.It was confirmed that there was difficulty detaching the coil from the delivery wire, the coil was repositioned 2-3 times.There was difficulty in retracting the wire/coil as it became stuck in the catheter.The coil did not remain in the target vessel, as it was removed along with the catheter and was found to be stretched.The coil was rotated both clockwise and counterclockwise, resulting in its failure to deploy.Subsequently, the procedure was completed by using another device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The patient was under anticoagulant therapy, and no additional embolic treatment methods were used during the procedure.The physician flushed the catheter before each attempt.A photo provided by the customer confirms the device failure.
Additional 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.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.
Additional Manufacturer Narrative
G1: contact office country: united states g1: manufacturing site country: united states 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 or Problem Description
In additional information received on (b)(6) 2025, it was reported that the junction zone was located out of the tip of the catheter during deployment.The user stated that when deploying the coil, the delivery wire was rotated counterclockwise 10 times but may have also been rotated clockwise a few times.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex g.Investigation ¿ evaluation.It was reported that the delivery wire included in retracta detachable embolization coil unraveled during a coil embolization procedure for endovascular aneurysm repair (evar) in a patient of unknown age and gender.The customer noted that there was no damage to the device upon opening the package.A pusher stylet was utilized for coil deployment and was advanced through the shipping cartridge without difficulty.The coil was introduced via a tortuous internal iliac artery.It was confirmed that there was difficulty detaching the coil from the delivery wire, the coil was repositioned 2-3 times.There was difficulty in retracting the wire/coil as it became stuck in the catheter.The coil did not remain in the target vessel, as it was removed along with the catheter and was found to be stretched.The coil was rotated both clockwise and counterclockwise, resulting in its failure to deploy.Subsequently, the procedure was completed by using another device.It was reported that the junction zone was located out of the tip of the catheter during deployment.The user stated that when deploying the coil, the delivery wire was rotated counterclockwise 10 times but may have also been rotated clockwise a few times.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The patient was under anticoagulant therapy, and no additional embolic treatment methods were used during the procedure.The physician flushed the catheter before each attempt.A photo provided by the customer confirms the device failure.Reviews of the documentation, including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu) for the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.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 device history record (dhr) for the device and related subassembly lots found one potentially related nonconformance, in which all nonconforming product was scrapped.It should be noted that there was one other complaint associated with the final product lot number for the same failure.Product labeling review: the current instructions for use [t_mwcer_rev6] state the following: ¿instructions for use 1.Perform an angiogram and measure the diameter of the vessel to be occluded.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.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.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.¿ evidence gathered upon review of upon 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, no product returned, and the results of our investigation, it was concluded that the cause of this event is an unintended use error.The customer stated that the junction zone was located outside of the catheter, as opposed to just inside the catheter tip as stated in the ifu.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook 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 or Problem 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
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK ING; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8004681379
• MDR Report Key: 21193279
• Report Number: 1820334-2025-00080
• Device Sequence Number: 8786064
• Product Code: KRD
• UDI-Device Identifier: 10827002342009
• UDI-Public: (01)10827002342009(17)290221(10)15909871
• Combination Product (Y/N): N
• PMA/510(K) Number: K151676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G34200
• Device Catalogue Number: MWCER-35-14-12
• Device Lot Number: 15909871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 01/23/2025; 08/12/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/13/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC/INTERLOCK.; JAPAN LIFELINE/AVENIR.; MEDICO'S HIRATA/POD PACKING COIL.
• Patient Sex: Unknown