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

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation - the device was not returned to assist with the investigation.If the complaint device becomes available for investigation, the device will be evaluated and the file will be updated at that time.The device was shipped with instructions for use (ifu), which provides the warnings, precautions, and instructions for use.In the instructions for use section, the ifu states "if the coil position is correct, use the torque device to turn the delivery wire counterclockwise 8-10 times, until coil detachment can either be felt or visualized under fluoroscopy.It is recommended that the junction remain just inside the tip of the catheter." the ifu in the coil delivery technique and coil size selection also states "in general, the first coil selected should have a diameter that is 20% larger, or 2 mm oversized, than the vessel that is being occluded." a complaint history search revealed this to be the only reported complaint associated to the complaint lot number 7130984.For this case, very limited information was available.No additional evaluation of the device was performed since the device was not returned, and images were not provided.No evidence was found indicating that the device was manufactured outside of cook inc.Specifications.Based on the description of event, it is likely that the event was caused by the user technique, however, at this time there is no objective evidence to determine if this complaint was caused by a procedural or device related circumstance.Thus the root cause of this event cannot be determined.Nevertheless, the appropriate personnel have been notified of this incident.No risk reduction measures are required at this time.
Event or Problem Description
During a pelvic congestion embolization procedure, the physician had inserted the retracta detachable embolization coil, but encountered difficulty to deploy.It was reported that the physician had to rotate the deployment wire about 30 times to get the coil to deploy (1820334-2017-00213).A second device of a larger size was reported to have been used during the same procedure.The attending physician also experienced difficulty deploying this device.The device wire broke while the attending was performing additional manipulation to deploy the coil (1820334-2017-00040).The physician obtained a competitors' device and successfully completed the procedure.No adverse patient consequences were reported.

• 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: 6304147
• Report Number: 1820334-2017-00213
• Device Sequence Number: 968471
• Product Code: KRD
• UDI-Device Identifier: 10827002341989
• UDI-Public: (01)10827002341989(17)210803(10)7130984
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2016

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 Model Number: N/A
• Device Catalogue Number: MWCER-35-14-8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1