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

Model Number G34199

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: lead tech.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 difficult to detach during placement in an aneurysmal sac off the right iliac artery.Tornado coils had already been placed in the aneurysmal sac.The inconel junction was placed half in the catheter and half out.The coil was manipulated many times (counterclockwise) in an attempt to detach it from the delivery wire, but was unsuccessful.The delivery wire unraveled.The coil was retracted back into the catheter and removed.Similar devices were placed to successfully complete the procedure.The patient was discharged home after the case.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Additional information: b5, d9 - product received on, h6 - annex g 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

Upon device return on 13dec2021, it was noted that the distal end of the coil had elongated/unraveled.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.Cook medical inc.Received a complaint from a representative at the (b)(6) medical center, located in (b)(6).The incident involved an mwcer-35-14-10, retracta detachable embolization coil from lot 13828813.It was reported the coil was planned to be deployed into a sac that was already somewhat filled with tornado coils.The inconel junction was placed half in the catheter and half out, but it never fully disconnected from the wire and started to uncoil within the patient.It was removed without any harm to the patient.A review of the complaint history, device history record, instructions for use (ifu), quality control procedures, and specifications of the device, as well as a visual inspection of the returned product, were conducted during the investigation.The mwcer-35-14-10, retracta detachable embolization coil was returned in a used and damaged condition.A visual examination confirmed the embolization coil was attached to the delivery wire, with evidence of the coil being elongated where the proximal end of the embolization coil is connected onto the distal tip of the delivery.Evidence of dried biological matter was present.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.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.¿ the information provided upon review of the dmr, ifu, and dhr suggests that the device was manufactured to specification.There are no nonconforming devices in house or out in the field.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.It is possible that the failure could have occurred due to improper handling of the device during deployment, difficult patient anatomy, inadequate product planning (sizing) or preparation for use.It is also possible that the junction was outside of the tip of the catheter during deployment.Without the support and stability of the catheter tip, it is difficult to release the coil.Keeping the junction just inside the catheter tip during release is stated in the ifu.However, the investigation conclusion for this complaint is cause traced to a 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: 12488877
• MDR Text Key: 272274429
• Report Number: 1820334-2021-02169
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341996
• UDI-Public: (01)10827002341996(17)260325(10)13828813
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2022

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: G34199
• Device Catalogue Number: MWCER-35-14-10
• Device Lot Number: 13828813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 12/13/2021; 06/29/2022
• Supplement Dates FDA Received: 12/15/2021; 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2021
• 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: COOK TORNADO COILS 8/4 QTY. 7