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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
It was reported that an (b)(6) male underwent a testicular vein embolization procedure.The sheath, catheter and wire were positioned in the internal iliac vein and a run was performed.The vessel measured 14mm in diameter.The vascular surgeon asked for the 16mm detachable coil.The coil tracked nicely up from the right side into the left internal iliac vein.The surgeon proceeded to detach the coil in counter clockwise position and kept repeating this without the coil detaching.It was then recommended that he pull both the coil and catheter out together.Upon inspection it was noticed the inconel hub was still intact, although the wire had looked to unravel.No additional procedure was required and there were no adverse effects to the patient.
Additional Manufacturer Narrative
Investigation - evaluation: a review of drawings, complaint history, device history records, instructions for use, manufacturing instructions, quality control data, and visual inspection/functional testing was conducted during the investigation.The embolization coils were returned with a wire guide and a catheter from another manufacturer.Part of the coil was still inside the catheter and not detached.Inserting the wire guide into the catheter did not advance the coil any farther.Rotating the wire counterclockwise did not detach the coil.Retracting the wire guide resulted in an irreversible retraction of the coil into the catheter.This made a detailed analysis (coil length, coil diameter, etc.) of the returned product difficult without damaging the catheter.According to the product information of the catheter (not manufactured by cook), the catheter has a nylon-rich polyurethane inner layer.The ifu for the cook retracta detachable embolization coil states, "the retracta detachable embolization coil is not recommended for use with polyurethane catheters or catheters with sideports.If a catheter with sideports is used, the embolus may lodge in the sideport or pass inadvertently through it.Use of a polyurethane catheter may also result in lodging of the embolus within the catheter." review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints on this lot for this failure mode.The root cause of this failure is most likely due to the use of this product with an incompatible device.Per the risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 5895966
• Report Number: 1820334-2016-00865
• Device Sequence Number: 18955876
• Product Code: KRD
• UDI-Device Identifier: 10827002342023
• UDI-Public: (01)10827002342023(17)180901(10)4486058
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K123712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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-35-14-16
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2016
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/23/2016
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR