MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore analysis cannot be performed.As per additional information no damage was noted to the device prior to use and the device was prepared as per direction for use (dfu) for this product.However, contrary to this - the additional information states that continuous flush was not maintained during the procedure which is against the dfu for this product.In the case of this complaint it most likely that the main coil prematurely detached separated inside patient due to intermittent flush maintained during the procedure, as per dfu maintaining continuous flush throughout the procedure is a critical requirement as lack of it can result in increased friction and other difficulties.Also as reported that a non-stryker microcatheter was used for performing the procedure it can also contribute to failure, leading to as reported premature deployment.Therefore an assignable cause of ¿user error¿ will be assigned to investigation.
Event or Problem Description
It was reported that during coil embolization the when advancing the subject coil through (non -stryker) microcatheter, the coil prematurely detached inside the microcatheter.The detached coil was removed together with the microcatheter and was exchanged with another new coil.No clinical consequences were reported due to the event.

• Brand Name: TARGET XXL 360 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7982079
• Report Number: 3008881809-2018-00450
• Device Sequence Number: 1194756
• Product Code: HCG
• UDI-Device Identifier: 07613327128307
• UDI-Public: 07613327128307
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

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 Expiration Date: 02/29/2020
• Device Catalogue Number: M0036181240
• Device Lot Number: 19600413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1