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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

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 the delivery wire of a retracta detachable embolization coil separated.The device was required for use during a fistula gram was to be placed in the brachial vein.During the procedure, when the user attempted to detach the coil, the delivery wire broke.The user attempted to grasp the wire fragment but was unsuccessful.As a result, the patient required a cut-down procedure to successfully removed the wire.No other adverse effects were reported for this incident.It should be noted this was the only coil placed.The physician did not flush the catheter before coil deployment.The torque device was used during deployment.The coil junction was within the tip of the catheter during deployment.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation on (b)(6) 2022, a representative of (b)(6) (united states) reported to cook the delivery wire of a retracta detachable embolization coil (rpn: mwcer-35-14-6; lot#: 14270736) separated.The device was required for placement in the brachial vein during a fistulagram procedure.During detachment of the coil, the delivery wire broke.Attempts to retrieve the wire were unsuccessful; therefore, a cutdown procedure was performed, and the wire fragment was successfully removed from the patient.The coil remains in the patient.It was reported that the physician did not flush the catheter prior to coil deployment with the torque device.The coil junction was noted within the tip of the catheter during deployment.No other adverse events were reported due to this occurrence.Reviews of the documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well a visual inspection of the retuned device, were conducted during the investigation.One used device in a damaged condition was returned to cook for evaluation.Device received in two sections.Cook did not confirm that the device was manufactured out of 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 dhr for the reported complaint device lot 14270736 revealed 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 t_mwcer_rev5 packaged with the device contains the following in relation to the reported failure mode: ¿precautions¿ prior to introduction of the embolization coil, flush the angiographic catheter with saline¿ instructions for use¿ 5.Remove the delivery wire holder and the metal loading cartridge from the catheter hub while holding the delivery wire stationary¿ 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.8.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¿ the information provided upon review of the dmr, dhr, and product labeling, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded the cause of this event was due to failure to follow instructions.The customer informed cook that the catheter was not flushed prior to coil introduction; this could have caused friction in the catheter which possibly caused damage to the junction and ultimately led to this failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• 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: 14088163
• MDR Text Key: 290160133
• Report Number: 1820334-2022-00560
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341972
• UDI-Public: (01)10827002341972(17)261024(10)14270736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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: N/A
• Device Catalogue Number: MWCER-35-14-6
• Device Lot Number: 14270736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2021
• 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
• Patient Outcome(s): Required Intervention