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

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, after the deployment of the nester platinum embolization microcoil, it was noted by the operator of the device that the coil size seemed different from what was indicated on the product label.The customer confirmed that no additional intervention was required, and no adverse events were reported.The circumstances surrounding the usage and handling of the device are not known.The coils also reportedly migrated.The product is reportedly not available for return; however, images and videos were provided for evaluation.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use, manufacturing instructions, specifications and quality control data, and visual inspection of provided videos were conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Per the instructions for use: ¿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.Precautions: perform an angiogram prior to embolization to determine correct catheter position.Prior to introduction of embolization coil, flush the angiographic catheter with saline.¿ instructions for use states to perform a final angiogram to confirm coil position within target vessel.Review of the device history record shows no nonconforming events which could contribute to this failure mode.A review of our complaint records determined that there are no additional complaints on the lot apart from this event.Based on the provided information, no product returned, and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and 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: 6862094
• Report Number: 1820334-2017-02897
• Device Sequence Number: 10942154
• Product Code: KRD
• UDI-Device Identifier: 00827002527379
• UDI-Public: (01)00827002527379(17)220213(10)7571545
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: MWCE-18-7-4-NESTER
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR