MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that the coil was confirmed to be in good condition prior to use and was prepared as per the dfu, no resistance was encountered during manipulation of the coil, and continuous flush was set up and maintained throughout the procedure.However, based on the information currently available the exact cause for the reported event cannot be determined.
Event or Problem Description
During the procedure, it was reported that the coil was prematurely detached in the rhv (rotating hemostatic valve) connecting with the microcatheter hub.No clinical consequences reported to the patient.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9288737
• Report Number: 3008881809-2019-00336
• Device Sequence Number: 11235906
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K153658
• 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): 11/06/2019

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: 12/08/2021
• Device Catalogue Number: M0035421520
• Device Lot Number: 21066654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHETER (STRYKER)