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

Model Number N/A

Device Problems Stretched (1601); Difficult or Delayed Separation (4044)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

It was reported a male patient required placement of a retracta detachable embolization coil for a left varicocele embolization procedure.During the procedure, the physician experienced difficulty detaching the coil for approximately two minutes.The torque device was used and the wire was turned counter clockwise.The wire was pulled back, and the coil eventually detached.However, the coil junction had unraveled.Imaging showed the coil was stretched inside the patient's vessel.The physician was satisfied with the coil placement, and the coil remains in the patient.Two similar coils were placed to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

A follow up report will be submitted should additional relevant information become available.

Event Description

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

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.

Event Description

In additional information, it was reported that the physician flushed the catheter before each coil deployment.The whole coil except "the inconel junction" exited the distal tip of the catheter.The coil junction was within the tip of the catheter during deployment.It was noted that the two coils placed following the event "would have been used regardless".

Manufacturer Narrative

D10: the beacon tip nb advantage catheter is a.035 8cm mpa (g11467).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

Investigation ¿ evaluation: on 21dec2021 cook medical received a complaint from a representative at the great lakes medical imaging center reporting a 19 year old male required placement of a retracta detachable embolization coil, mwcer-35-14-8 lot 13863796, and the beacon-tip nb advantage angiographic catheter for a left varicocele embolization procedure.The physician used the torque device and turned the wire counter clockwise per ifu.The physician experienced difficulty detaching the coil for approximately two minutes.The wire was pulled back, and the coil eventually detached.The whole coil except the inconel junction exited the distal tip of the catheter.However, the coil junction had unraveled.Imaging showed the coil was stretched inside the patient's vessel.The catheter was flushed before each coil deployment.Two nester coils were placed following the retracta coil placement.The physician was satisfied with the coil placement, and the coil remains in the patient.The patient did not experience any adverse effects or require additional procedures.A review of the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu) 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 dhrs for the reported complaint device lot 13863796 and the related sub-assembly coil lot sa13862678 and wire lot sa13833901 did not have any relevant non-conformances.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, cook medical inc.Has concluded that there is no evidence that non-conforming product exists in house, in the field and that device was manufactured to current specification.Cook also reviewed product labeling.The product¿s instructions for use [ifu], ¿retractatm detachable embolization coils¿ [t_mwcer_rev5], provides the following information to the user related to the reported failure mode: intended use: ¿the retracta detachable embolization coil is intended for arterial and venous embolization in the peripheral vasculature.¿ warnings: ¿the retracta detachable embolization coil is not recommended for use with polyurethane catheters or catheters with sideports.If a catheter with sideports is used, the embolus may lodge in the sideport or pass inadvertently through it.Use of a polyurethane catheter may also result in lodging of the embolus within the catheter.¿ precautions: ¿prior to introduction of the embolization coil, flush the angiographic catheter with saline.¿ product recommendations: ¿the following catheters are recommended for use with retracta detachable embolization coils: hnb(r)4.0-35, hnb(r)5.0-35, hnb(r)5.0-38, scbr-5.0-38, scbr-4.0-38.¿ 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.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 the coil detachment can be either felt or visualized under fluoroscopy.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the results of the investigation, cook medical has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.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 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
• 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: 13158311
• MDR Text Key: 283304938
• Report Number: 1820334-2022-00018
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341989
• UDI-Public: (01)10827002341989(17)260421(10)13863796
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-8
• Device Lot Number: 13863796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/10/2022; 03/02/2022; 09/21/2022
• Supplement Dates FDA Received: 02/01/2022; 03/18/2022; 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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: BEACON-TIP NB ADVANTAGE CATHETER; COOK NESTER COILS (QTY 2)
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Race: White