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

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a retracta detachable embolization coil was unable to detach from the delivery wire.Additional information regarding event details and patient outcome has been requested but is currently unknown.

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

Additional information was provided on 27jan2022.Prior to the use of the cook retracta detachable embolization coil for the embolization of a segmental right branch of the portal vein, polyvinyl alcohol pva was used for distal embolization.Upon opening the package of the cook retracta detachable embolization coil, no damage to the device was noted.The patient was described as having normal anatomy and no significant angulation.The patient was not taking any anti-coagulant medication at the time of the procedure.The target vessel size was approximately 10-12 mm.The first coil deployed through the catheter was a competitors coil.The catheter was flushed with heparinized saline before the deployment of the cook retracta detachable embolization coil.The coil was not repositioned before deployment was attempted.While advancing to the delivery site, the device was not rotated.The provider stated that multiple turns were made to detach the coil.The coil was removed and another coil was deployed.After the removal of the coil it was reported that the coil looked "relatively ok." the patient did not experience an adverse event as a result of the failure.

Manufacturer Narrative

Investigation ¿ evaluation.Cook inc.Received a complaint from (b)(6) hospital in basingstoke, uk stating that an mwcer-35-14-14 (retracta detachable embolization coil) from lot 13965161 would not deploy in a patient.No damage was noted to the device prior to use, and the patient had normal anatomy with no significant angulation.The user rotated the device several times but the coil would not detach from the delivery wire.The device was removed and a new coil was placed to complete the procedure.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device, as well as a visual inspection and functional test of the returned product, were conducted during the investigation.The mwcer-35-14-14 was returned in a used and damaged condition.A visual examination confirmed the embolization coil was attached to the delivery wire, with evidence of dried biological matter.During table top testing, following the supplied ifu instructions, the coil was able to be removed from the delivery wire end coil, with approximately 9 counterclockwise turns.The proximal end of the embolization coil and the distal end of the delivery wire end coil were free of damage.Additionally, a document based investigation evaluation was performed.A device master record (dmr) review was performed, and device manufacturing instructions and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) and relevant sub-assembly lots record no non-conformances.A database search revealed no other complaints have been reported for the device lot.The device is shipped with instruction for use (ifu) which 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.¿ the review of the dhr, dmr, and returned device concluded the device was manufactured to specification and that there are no nonconforming devices in house or out in the field.Based on the information provided, the examination of returned product and the results of the investigation, the root cause conclusion for this complaint is component failure without a manufacturing or design deficiency.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.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 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: 13089676
• MDR Text Key: 290452046
• Report Number: 1820334-2021-02737
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002342016
• UDI-Public: (01)10827002342016(17)260601(10)13965161
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• 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-35-14-14
• Device Lot Number: 13965161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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: AZURE COIL; REUT CATHETER