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

Model Number	M0035421520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
The sticker was found on a usage book with a note "snapped".No other information was provided.
Additional Manufacturer Narrative
The device history record review confirms 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.There are many potential root causes for the as reported event, however a review and analysis of all available information cannot determined the exact cause for the reported coil break.
Event or Problem Description
The sticker was found on a usage book with a note "snapped".No other information was provided.

• 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: 6985056
• Report Number: 3008881809-2017-00457
• Device Sequence Number: 18954612
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: (01)04546540697981(17)190831(10)19222431
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113412
• 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,Followup
• Report Date (Section B): 12/11/2017

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 Expiration Date: 08/31/2019
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 19222431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1