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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2017
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
International customer reported that the microcoil dropped from the cannula when they opened the package.There was no patient contact, accordingly no adverse patient consequences were reported.The device was received for evaluation.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation: a review of documentation, instructions for use, device history record, complaint history, manufacturing instructions, visual inspection, specification and quality control data was conducted during the investigation.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record for all applicable lots and subassembly lots was performed and found that no nonconformances related to the failure mode were recorded.Additionally, there have been no additional complaints reported for the complaint lot.One shipping cannula was returned with a coil partially pushed out of the end.No bracket holder was returned on or with the device.Tipping/moving the shipping cannula around did not result in further movement of the coil.The coil was gently removed from the cannula for inspection.There did not appear to be any damage to the coil or the cannula.There was no evidence of biomatter.The device dimensions were verified and found to be in specification.According to manufacturing documentation, the coil is properly placed into the shipping cannula during quality control inspection.The holder bracket is then placed into the hub and distal end of the cannula to confine the coil during shipping.It is confirmed that the coil is not protruding.It is possible that the bracket holder was not attached to the device as specified, resulting in dislodgement of the coil during shipping and handling, although there is no evidence to confirm.It is also possible that after the bracket holder was removed (upon opening the package) the shipping cannula was shaken or the introducer stylet was prematurely introduced into the hub resulting in the coil partially dislodging.The instructions for use (ifu) pictorially depicts and instructs to first place the shipping cannula into the microcatheter, to secure the shipping cannula to the catheter using the adapter, and then inserting the introducer stylet into the shipping cannula.Based on the provided information, inspection of returned product 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: TORNADO PLATINUM EMBOLIZATION MICROCOIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6597630
• Report Number: 1820334-2017-01284
• Device Sequence Number: 16379678
• Product Code: KRD
• UDI-Device Identifier: 00827002082595
• UDI-Public: (01)00827002082595(17)220220(10)7591401
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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-18S-6/2-TORNADO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1