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	03/22/2017
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 tornado platinum embolization microcoil dropped from the cannula when they opened the package.The device was intended to be used for an unspecified vessel embolization procedure.The event occurred prior to use.A replacement device was obtained.There are no adverse patient consequences.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation.A review of device history record, manufactures instructions, a visual inspection, 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 the coil is placed in a shipping cannula and held in place by a holder bracket.In order for the coil to fall from the package , both the shipping cannula and the holder bracket would have to fail.The bracket was not returned and the loose coil, which was visible in customer images, was not found with the returned product.It is feasible that the coil fell from the shipping cannula due to inadequate tightening by manufacturing.It is also feasible that the end user removed the holder bracket prematurely, causing the coil to dislodge.Based on the available information, the root cause is most likely package handling related.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: 6506921
• Report Number: 1820334-2017-00714
• Device Sequence Number: 19053672
• Product Code: KRD
• UDI-Device Identifier: 00827002082595
• UDI-Public: (01)00827002082595(17)220119(10)7549461
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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: 03/27/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1