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

Model Number	N/A
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook 5fr-80cm-rc1 catheter.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported an unknown patient required placement of a tornado platinum embolization coil for vascular embolization in the internal iliac artery.During the procedure, the operator noted part of the coil exited the tip of the catheter, but the rest of the coil got stuck inside the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D11 ¿ concomitant medical products: cook hnb5.0-38-80-p-ns-rc1, terumo 0.035 inch wire, d10 ¿product received on: 02jun2020.Investigation ¿ evaluation a representative from (b)(6) hospital informed cook of an incident involving a tornado platinum embolization coil.On (b)(6) 2020 during a vascular embolization procedure in the internal iliac artery, the coil came out of the tip of the catheter.The doctor kept pushing the wire,so the coil could be fully released.However, the doctor felt resistance and was unable to push the coil forward.The coil became stuck inside the catheter.A 0.035 inch wire was used to push the coil through a.038" catheter.The catheter with the stuck coil was removed from the patient¿s body and a new device was used to complete the procedure.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.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection and functional test, were conducted during the investigation.The complainant returned the complaint device for investigation.Physical examination of the returned device showed one 5fr cook catheter having a.038" end hole was returned used with biomatter present.Approximately 7.2cm of the mwce coil is exiting the distal end of catheter.There is no damage to the catheter or the coil.A functional test using a 0.035" wire guide was performed to see if the coil could be released from the distal end of the catheter.The coil could not be released.Based on the returned device, there is no evidence the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Adequate risk controls are in place to inhibit this failure mode.The device history record (dhr) for the complaint lot revealed one reported non-conformance.The non-conformance is for ¿stretched coil¿ that affected a quantity of 1 with a disposition of scrapped.There are 100% inspections in place to check for this non-conformance before released.A database search revealed no other complaints have been reported for the device lot.At this time, there are nonconforming devices in house or out in the field.As there are adequate inspection activities established, objective evidence that the dhr was fully executed and no additional complaints from the same lot.It was concluded that there is no evidence that nonconforming product exists in house or in field.The product¿s instructions for use [ifu], ¿tornado embolization coils and microcoils¿, provides the following information to the user related to the reported failure mode: warnings: "tornado embolization coils are 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: ".035 and.038 inch (.89mm and 0.97mm) diameter, tfe-coated wire guides with flexible tapered tips are recommended for positioning tornado embolization coils.¿ the following table offers specific recommendations.Coil size diameter wire guide type & size catheter type & size.035 inch , tsfnb-35 , hnbr)4.1-35, tsfna-35 , hnb(r)5.0-35, tsfb-35 , hnb6.0-35, tsfbp-35 , scbr5.0-35.Tsf-35, 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." it is possible that unknown procedural issues led to the failure.If the catheter was not adequately flushed prior to deployment of the coil, it could have caused the coil to become stuck.Cook's ifu recommends using an.035" wire guide and.035" catheter for.035" embolization coils.The customer indicated they used a 0.035¿ wire guide and a 0.038¿ catheter.It is possible that the gap between the coil and catheter was too large, resulting in the coil becoming lodged in the catheter.Based on the information provided, inspection of returned product and the results of the investigation, it was determined that a possible cause of this event is an unintended use error.The appropriate personnel have been notified.Per the quality engineering 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 or Problem Description
Additional information received 17may2020 indicated the physician took out the catheter out of the patient's body.Another similar catheter was used to complete the procedure.

• Brand Name: TORNADO PLATINUM EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10055963
• Report Number: 1820334-2020-00954
• Device Sequence Number: 2501872
• Product Code: KRD
• UDI-Device Identifier: 00827002104136
• UDI-Public: (01)00827002104136(17)240226(10)9505001
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K153778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2024
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-10/5-TORNADO
• Device Lot Number: 9505001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/17/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1