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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
During a varicocele embolization to spermadic vein procedure on the (b)(6) year old male patient, the coil unraveled inside the vein and parts of it ended in the renal vein.The ir had to use vascular retrieval forceps to remove the parts of the coil.No piece of the device remained in the patient's body.No adverse effects to the patient were reported due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation / evaluation: a review of complaint history, the device history record, drawings, instructions for use (ifu), manufacturing instructions, specifications, quality control and a visual inspection of the returned device were conducted during the investigation.The returned coil was trapped by the snare and was inside the distal tip of the company's catheter.We were able to remove the coil and snare through the distal end of the catheter.We then ran a 0.035 wireguide through the catheter and found no occlusion or evidence as to why the coil might have been caught in the catheter.During the inspection, the tip of the catheter was damaged.There was approximately 2.6 cm of the proximal end of the coil intact.The remainder of the coil was completely unraveled.The weld from the distal tip could not be located.Due to the unraveling, we are unable to confirm if the coil was manufactured dimensionally to specification.A review of production records showed that during the production of lot 6047618, there were no nonconformances during the manufacturing process.The device is shipped with ifu.The ifu gives device description, intended use, warnings, precautions, product recommendations and instructions for placement of the device.The ifu includes the instruction in step 6, "perform final angiogram to confirm coil position within the target vessel." based on the information provided and review of the device, we are unable to draw a conclusion as to why the coil unraveled.Per the quality engineering risk assessment, no further action is required.We have notified the appropriate internal personnel and will continue to monitor for similar events.
Event or Problem Description
During a varicocele embolization to spermadic vein procedure on the (b)(6) year old male patient, the coil unraveled inside the vein and parts of it ended in the renal vein.The ir had to use vascular retrieval forceps to remove the parts of the coil.No piece of the device remained in the patient's body.No adverse effects to the patient were reported due to this occurrence.Additional information received on 14 april 2016 stated: the coil unraveled whilst in the catheter.The doctor said it felt like the proximal end of the coil was stuck in the catheter (under imaging part of the coil could be seen proximal to the rest of the coil in the catheter).The doctor tried to spin the catheter and push the coil to get it out but this did not help.It appeared that the coil had come undone from the distal end and caught inside the catheter.The doctor inserted a micro snare through the same catheter and snared the coil.He tried to pull it back into the sheath but he couldn't get it in so he pulled the sheath, catheter, coil (inside and outside of the catheter) through the heart and out of the patient.

• Brand Name: NESTER PLATINUM EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5550828
• Report Number: 1820334-2016-00218
• Device Sequence Number: 895677
• Product Code: KRD
• UDI-Device Identifier: 00827002269927
• UDI-Public: (01)00827002269927(17)200914(10)6047618
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-14-12-NESTER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2016
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR