MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443040
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that as the coil was being advanced, it prematurely detached and migrated.The physician attempted to retrieve the coil but was unsuccessful.No further information is available.
Additional Manufacturer Narrative
Expiration date/manufacturing date: added.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.Based on the information currently available the exact cause for the reported issue cannot be determined.
Event or Problem Description
It was reported that as the coil was being advanced, it prematurely detached and migrated.The physician attempted to retrieve the coil but was unsuccessful.No further information is available.

• Brand Name: TARGET 360 NANO 3 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6517213
• Report Number: 3008881809-2017-00122
• Device Sequence Number: 19231142
• Product Code: HCG
• UDI-Device Identifier: 07613252600336
• UDI-Public: (01)07613252600336(17)191031(10)19370880
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: M0035443040
• Device Catalogue Number: M0035443040
• Device Lot Number: 19370880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention