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

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation begun but not yet complete.This report is being submitted as a part of a remediation effort regarding difficult deployment of retracta embolization coils.Upon review of this complaint due to an ous regulatory inquiry, it was determined the initial reportability assessment was incorrect.Further investigation is being conducted and a final report will be submitted upon completion of the investigation.

Event Description

It was reported a (b)(6), male patient required a series of retracta detachable embolization coil for portal vein embolization.A percutaneous puncture was made into the portal venous system of the right lobe of the liver.An 11 centimeter 6 fr competitor sheath was in situ.The plan was to embolize multiple branches of the right lobe of the liver.The catheter was positioned for placement.The junction zone of the delivery wire was correctly positioned and the torque deployment device was utilized for each coil.The operator reported difficultly deploying several of the retracta coils.The following provides information regarding the coils that experienced deployment difficulties and their corresponding reports: reported under patient identifier (b)(6): coil #1 - required approx.30-35 turns to deploy reported under patient identifier (b)(6): coil #2 - required approx.30-35 turns to deploy reported under patient identifier (b)(6): coil #3 - required approx.25-30 turns to deploy reported under patient identifier (b)(6): coil #6 - required approx.15 turns to deploy.Coil was seen to be exiting catheter at an acute 90 degree angle, but reportedly still deployed relatively easily.(this report) reported under patient identifier (b)(6): coil #7 - after approximately 25 counterclockwise rotations of the delivery wire, the coil would not deploy.The operator was concerned about losing access due to the precise positioning required, so the device was removed.A competitor's coil was used without incident.Reported under patient identifier (b)(6): coil #10 - required approx.25-30 turns to deploy as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional method code: testing of model variant (4104).Investigation - evaluation.(b)(6) from (b)(6) hospital in the united kingdom informed cook on 06mar2019 of an incident involving a retracta detachable embolization coil [rpn: mwcer-35-14-10] from lot number 8835456.On (b)(6) 2019, during a portal vein embolization procedure, there was difficulty detaching the coil.The coil required approximately 15 turns to deploy.The coil was exiting the catheter at an acute 90 degree angle, but still deployed easily.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence, and there have been no adverse effects to the patient due to this occurrence.The physician used the provided pin vice and the device was in the required position of the catheter tip.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, an image was provided of the patient anatomy and coil placement within the patient.The image shows multiple coils deployed within the patient.Cook has concluded that the device was manufactured to specification.Additionally, 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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (8835456) and the related delivery wire subassembly lot revealed no non-conformances relevant to the failure mode.A database search identified two other events associated with the reported device lot.In all three events, the coils were successfully deployed within the patient(s) and no evidence of a manufacturing or device design deficiency was found.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, and no related non-conformances, cook has concluded that there is no evidence that nonconforming product exists either in house or in field.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: 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." 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, no product returned, and the results of our investigation, a definitive root cause for this event has been traced to component failure unrelated to a deficiency in manufacturing/device design.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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
• MDR Report Key: 11117054
• MDR Text Key: 239672598
• Report Number: 1820334-2021-00008
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341996
• UDI-Public: (01)10827002341996(17)230503(10)8835456
• Combination Product (y/n): N
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2023
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-10
• Device Lot Number: 8835456
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 TERUMO AZUR COILS; 8 OTHER COOK 35 MM RETRACTA COILS; CORDIS / C2 / 4FR CATHETER; CORDIS 6FR 11CM SHEATH
• Patient Age: 49 YR