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

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a female patient required a retracta detachable embolization coil for treatment of pelvic congestion.Upon opening the package, the device was intact.The coil advanced through the selective catheter without difficulty.However, despite turning the wire, the coil was impossible to detach from the delivery wire and would not deploy.The device was removed and inspected and no damage was noted.The procedure was completed with another device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a female patient required a retracta detachable embolization coil for treatment of pelvic congestion.Upon opening the package, the device was intact.The coil advanced through the selective catheter without difficulty.However, despite turning the wire, the coil was impossible to detach from the delivery wire and would not deploy.The device was removed and inspected and no damage was noted.The procedure was completed with another device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Clinique du parc (france) informed cook on 07feb2022 of an incident involving an mwcer-35-14-14 (retracta detachable embolization coil) from lot 14341430.It was reported that the user was unable to detach the coil from the delivery wire during an embolization procedure.The coil was not difficult to advance through the selective catheter, and no damage was noted to the device prior to use.The device was removed and a new device was used to complete the procedure.There were no adverse effects reported to the patient due to this incident.Reviews of documentation including the complaint history, device history record (dhr), quality control, and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; however, a document-based investigation evaluation was performed.A review of the device master record (dmr) found 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 (14341430) revealed no relevant non-conformances.A database search did not identify any other events associated with the reported device lot.Cook also reviewed product labeling.The current instructions for use [t_mwcer_rev5] state the following: instructions for use: 1.Perform an angiogram and measure the diameter of the vessel to be occluded.2.Firmly grasping the loading cartridge between thumb and forefinger, introduce the metal end of the loading cartridge into the base of the catheter hub.Lock the loading cartridge onto the catheter hub by turning the luer lock adapter clockwise.3.Unlock the white safety clip and advance at least 30 cm of the delivery wire into the catheter so that the coil is fully loaded in the catheter.4.Unlock the loading cartridge from the catheter hub by turning the luer lock adapter counter-clockwise.5.Remove the delivery wire holder and the metal loading cartridge from the catheter hub while holding the delivery wire stationary.Remove the torque device and reserve it for use later in the procedure.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 just inside the catheter tip.Note: advancing the delivery wire slowly allows the junction to be seen more 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.Note: do not turn the delivery wire counter-clockwise during advancement; the coil may be unintentionally detached.7.Verify correct position of the coil fluoroscopically.If coil position or placement is not satisfactory, the coil may be retracted into the catheter and re-deployed so long as there significant resistance.Note: it may be possible to perform a test injection of contrast media using a tuohy-borst sidearm adapter while the delivery wire is in the catheter.Note: if the size of the coil is not correct, gently remove the entire delivery wire and coil.Do not use the coil again.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.Note: do not advance the delivery wire after the coil is detached.9.Gently remove the delivery wire after coil detachment.10.Additional retracta or pushable coils may be required to achieve permanent occlusion of the vessel.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of device master record, product labeling review, and the device history record did not confirm that the device was manufactured out of specification.There is not evidence that items in the lot or similar devices in the field or in house are nonconforming.Based on the available information, 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.It is possible that the user did not have the junction in the correct position when this failure occurred, but this cannot be 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 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 INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13548946
• Report Number: 1820334-2022-00242
• Device Sequence Number: 20147701
• Product Code: KRD
• UDI-Device Identifier: 10827002342016
• UDI-Public: (01)10827002342016(17)261130(10)14341430
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: N/A
• Device Catalogue Number: MWCER-35-14-14
• Device Lot Number: 14341430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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: TWO MWCER-35-14-12; TWO MWCER-35-14-14
• Patient Sex: Female