MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2019
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 reported issue is covered in the device directions for use.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.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available, the exact cause for the reported event cannot be determined.The device is not available to the manufacturer.
Event or Problem Description
It was reported the coil prematurely deployed in the microcatheter; there was no reported clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8746460
• Report Number: 3008881809-2019-00188
• Device Sequence Number: 11182460
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• Combination Product (Y/N): N
• 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): 06/28/2019

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: 06/24/2021
• Device Catalogue Number: M0035424150
• Device Lot Number: 20664888
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1