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

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 5fc2 cobra, catheter.038 fa.Cordis, azur c35 system coils.Pma/510(k) #: k151676 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 retracta detachable embolization coil for an embolization of esophageal varices.During the procedure, the operator reported the coil got stuck in the distal third of the catheter.As stated, "maybe 80% of the coil has been pushed out of the c2 catheter, then stucked." the catheter was removed and a competitor's device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D10 ¿ product received on: 07nov2019.Investigation evaluation: a customer at (b)(6) (germany) informed cook that a retracta detachable embolization coil became stuck in a 5.0fr.038¿ catheter during an esophageal varices embolization.During advancement, the retracta became lodged in the distal end of the catheter, with approximately 80% of the coil extending from the catheter's distal tip.The user could not move the coil forwards or backwards, and removed the catheter and coil as a unit.They reinserted the catheter, and successfully placed a new, similar coil.The patient did not experience adverse effects.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, visual inspection, and dimensional verification, were conducted during the investigation.The customer returned one used and damaged retracta coil with the delivery system.The coil was detached from the delivery system.The customer also provided a cd containing images of the lodged coil within the mentioned 5fr c2 catheter.The coil is covered in biological matter and is elongated throughout.The weld ball is present and fully attached to the coil.The coil measures approximately 18.5 cm in length.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) was reviewed.The complaint device lot revealed no nonconformances.A database search revealed one complaint on the device lot.There is no evidence of nonconforming material or additional complaints from this lot in the field.The instructions for use for the device state the following: "warnings: the retracta detachable embolization coil is not recommended for use with polyurethane catheters or catheters with side ports.If a catheter with sideports is used, the embolus may lodge in the sideport or pass inadvertently through it.Use of a polyurethane catheter ay also result in lodging of the embolus within the catheter.Instruction 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 oil 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." the instructions for use provide guidance on correct advancement of the device.Based on information provided, inspection of the returned product and results of the investigation, it was concluded the customer reported the coil became stuck during advancement, and that 80% of the coil had exited the catheter prior to the failure.It is possible that the.038" catheter had a larger inner diameter than recommended for the.035" retracta coil, causing the blockage.However, this cannot be confirmed.Cook established that a possible cause for this event is unintended use error in device selection.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
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
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9629222
• Report Number: 1820334-2020-00206
• Device Sequence Number: 2396574
• Product Code: KRD
• UDI-Device Identifier: 10827002342009
• UDI-Public: (01)10827002342009(17)230503(10)8835454
• Combination Product (Y/N): N
• 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): 02/25/2020

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: 05/03/2023
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-12
• Device Lot Number: 8835454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1