MAUDE Adverse Event Report: COOK INC TORNADO PLATINUM EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number N/A

Device Problems Material Separation (1562); Stretched (1601); Activation Failure (3270); Patient Device Interaction Problem (4001)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 10/03/2020

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: risk manager.Pma/510(k) #: preamendment.(b)(4).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 received via fda3500a form that an (b)(6) year old patient required a tornado platinum embolization coil for an unknown procedure.After the coil was deployed in the patient, it was noticed that the coil did not "coil up" and remained mostly straight.The physician did not want to block the hepatic artery and possibly cause thrombosis so the coil is believed to have been removed.Additional information regarding the event and patient outcome has been requested but is currently unavailable.No other adverse effects were reported.

Event Description

Additional information including the remainder of the text from the 3500a form was received 20oct2020.The procedure was an sp visceral angiography.The "coil retrieval resulted in the exterior unwinding and the inner core of the coil remaining." there was no harm to the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b3, b5, d4, h4, h6 - device code.Correction: h6 - patient code.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

Preliminary examination of the returned device on 04nov2020 showed the weld ball missing.The was total coil elongation and there were no fibers present on the coil.Additional information provided 16nov2020 stated the "core" of the coil was snared multiple times but could not be removed from the gastroduodenal artery.The artery was successfully embolized and the portion of the coil remains in the patient without harm.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5, h6-device code 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.(b)(6) from (b)(6) hospital in the united states informed cook on 14oct2020 of an incident involving a tornado platinum embolization coil [rpn: mwce-35-8/5-tornado] from lot number 9642566.On (b)(6) 2020, during a sp visceral angiography procedure, a coil was deployed in the patient and the shape of the coil remained mostly straight.Due to the shape, the doctor decided to remove the coil.In the process of removing the coil, the coil unraveled and separated within the patient.The separated piece was attempted to be snared multiple times, but could not be retrieved and was left in the patient.The gda (gastroduodenal artery) was embolized and there was no harm to the patient.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.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One used coil was returned to cook for evaluation.Upon visual inspection, the coil appeared to be totally elongated.The end coil was noted to be present.No fibers were noted and the weld ball was missing.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 (9642566) and the related coil subassembly lots revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no non-conformances, and no additional events from the same lot, cook has concluded that there is no evidence suggesting that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product¿s instructions for use [ifu], ¿tornado embolization coils and microcoils¿ [t_ce_tem_rev3], provides the following information to the user related to the reported failure mode: device description: "the embolization coil is supplied preloaded in the loading cartridge.Longer coil length and tornado-like configuration in deployed state maximize coil exposure to cross-section of lumen for disruption of blood flow.¿ warnings: "if difficulties occur when deploying the embolization coil, repeat coil release procedure.If difficulties persist, withdraw the wire guide, coils and angiographic catheter simultaneously as a unit.¿ precautions: "prior to introduction of the embolization coil, flush the angiographic catheter with saline." instructions for use: for 0.035 and 0.038 inch coils: "2.Firmly grasp the loading cartridge between thumb and forefinger.Introduce the metal end of the loading cartridge into the base of the catheter hub.Lock loading cartridge onto catheter hub by turning luer lock adapter clockwise.3.Maintaining position of the cartridge, advance the stiff portion of the wire guide into the loading cannula.Push the coil into the first 20 to 30 cm of the angiographic catheter.Remove the wire guide and loading cartridge.4.With the flexible tip of the wire guide, advance the embolization coil to the tip of the catheter.Verify position of the angiographic catheter prior to deployment.5.Deploy the coil by advancing the wire guide past the tip of the catheter." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, evaluation of the returned product, and the results of the investigation, a definitive root cause for this event has been traced to component failure without a deficiency in manufacturing/device design.If the patient¿s anatomy is tortuous, this may have changed the shape of the coil; however, without additional information, this cannot be confirmed.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: TORNADO PLATINUM EMBOLIZATION COIL
• Type of Device: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10729179
• MDR Text Key: 213039868
• Report Number: 1820334-2020-01929
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-8/5-TORNADO
• Device Lot Number: 9718651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 60