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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
A gooseneck snare was being used to retrieve a malpositioned coil during an arteriovenous (av) fistula procedure and the coil reportedly came apart into two pieces.The inner part of the coil remained straight and the outer part of the coil correctly coiled.Both pieces of the coil were able to be retrieved using the gooseneck snare.A second coil was placed and again, a gooseneck snare was being used to retrieve the coil as it was malpositioned.The exact same event occurred with the second snare.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Product has not been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
A gooseneck snare was being used to retrieve a malpositioned coil during an arteriovenous (av) fistula procedure and the coil reportedly came apart into two pieces.The inner part of the coil remained straight and the outer part of the coil correctly coiled.Both pieces of the coil were able to be retrieved using the gooseneck snare.A second coil was placed and again, a gooseneck snare was being used to retrieve the coil as it was malpositioned.The exact same event occurred with the second snare.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), trends and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: warnings: "positioning of embolization coils should be done with particular care.Coils should not be left too close to the inlets of arteries and should be intermeshed with previously placed coils if possible.¿ "a minimal but sufficient arterial blood flow should remain to hold the coils against the previously placed coils until a solid clot ensures permanent fixation.The purpose of these suggestions is to minimize the possibility of loose coils becoming dislodged and obstructing a normal and essential arterial channel.¿ the warning section also states, ¿embolization coil is not recommended for use with polyurethane catheters or catheters with sideports." and "if difficulties occur when deploying the embolization coils, withdraw the wire guide, coil, and angiographic catheter simultaneously as a unit." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NESTER PLATINUM EMBOLIZATION MICROCOIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5865855
• Report Number: 1820334-2016-00800
• Device Sequence Number: 11140291
• Product Code: KRD
• UDI-Device Identifier: 00827002269897
• UDI-Public: (01)00827002269897(17)210422(10)6807088
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2016

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-18-14-6-NESTER
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 11/09/2016; 01/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention