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

Model Number G34198

Device Problems Material Separation (1562); Difficult or Delayed Separation (4044)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Postal code: (b)(6).Phone: (b)(6).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 an unknown patient required a retracta detachable embolization coil for an internal iliac embolization procedure.During the procedure, the coil was partially deployed into the right internal iliac but failed to detach from the delivery wire.The wire was retracted and advanced again.The coil reportedly "prolapsed" into the external iliac, so the coil was repositioned in the catheter tip.Resistance was noted upon rotating the wire, and the wire was pulled back.The delivery wire separated, leaving the coil, inconel junction, and a 3cm portion of wire in the patient.The wire fragment was stented in place against the right iliac vessel as part of a planned endovascular aneurysm repair (evar) procedure.The wire fragment remains in the patient.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation.Althea services ltd.Informed cook of an incident involving an mwcer-35-14-8 (retracta detachable embolization coil) from lot 14300281.The device was required for embolization of the right internal iliac artery during an endovascular aneurysm repair (evar) procedure.After successfully placing two coils (rpn: mwcer-35-14-10 and mwce-35-20-10-nester), the user attempted to deploy a third coil via a competitor¿s catheter (4fr c2, cordis).The inconel junction was visualized inside the catheter tip and the delivery wire was rotated counterclockwise 8 times; however, the coil did not detach.The delivery wire was retracted, and the user confirmed the coil was still attached.The coil was advanced a second time until the inconel junction was again seen in the catheter tip; however, this time the coil prolapsed into the external iliac artery.The coil was again repositioned, and deployment was attempted.The inconel junction was within the catheter tip; however, when the delivery wire was rotated (approximately 10-15 turns), resistance was encountered, and no coil bundle spin was observed.The delivery wire was then retracted, and the device separated.Imaging was performed and approximately 3cm of the delivery wire was seen attached the coil inside the patient.The separated portion of the delivery wire was retained in the patient between the iliac artery wall and the ipsilateral leg graft of the evar.The procedure was successfully completed.No other adverse events were reported due to this occurrence.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned product, was conducted during the investigation.One device was received in a used condition.The distal coiled end of the delivery wire was separated.Additionally, a document based investigation evaluation was performed.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.In response to this incident, cook reviewed the device history record (dhr).The dhr for lot 14300281 and delivery wire subassembly lot records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: "instructions for use: perform an angiogram and measure the diameter of the vessel to be occluded.Firmly grasping the loading cartridge between thumb and forefinger, introduce the metal end of the loading cartridge into the base of the catheter hub.Lock the loading cartridge onto the catheter hub by turning the luer lock adapter clockwise.Unlock the white safety clip and advance at least 30 cm of the delivery wire into the catheter so that the coil is fully loaded in the catheter.Unlock the loading cartridge from the catheter hub by turning the luer lock adapter counter-clockwise.Remove the delivery wire holder and the metal loading cartridge from the catheter hub while while holding the delivery wire stationary.Remove the torque device and reserve it for use later in the procedure.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.Note: do not turn the delivery wire counterclockwise during advancement; the coil may be unintentionally detached.Verify correct position of the coil fluoroscopically.If coil position or placement is not satisfactory, the coil may be retracted into the catheter and re-deployed so long as there is no significant resistance.Note: if the size of the coil is not correct, gently remove the entire delivery wire and coil.Do not use the coil again.If the coil position is correct, use the torque device to turn the delivery wire counterclockwise 8-10 times, until coil detachment can be either felt or visualized under fluoroscopy.Note: it is recommended that the junction remain just inside the tip of the catheter.Note: do not advance the delivery wire after the coil is detached.Gently remove the delivery after coil detachment." how supplied: upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the device master record, product labeling, and the device history record indicated the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.It was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate 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: 13507873
• MDR Text Key: 287416284
• Report Number: 1820334-2022-00196
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341989
• UDI-Public: (01)10827002341989(17)261101(10)14300281
• Combination Product (y/n): N
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34198
• Device Catalogue Number: MWCER-35-14-8
• Device Lot Number: 14300281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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: CORDIS 4F C2 CATHETER; MWCE-35-20-10-NESTER QTY 1; MWCER-35-14-10 QTY 2
• Patient Outcome(s): Required Intervention; Other