MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035466300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains in patient.
Event or Problem Description
During the coil embolization procedure, it was reported that the main coil prematurely detached outside the aneurysm and the main coil was left in the patient.There was a slight delay to the surgical and the aspirin was provided to the patient as a result of the reported event.No further information is available now.
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 neither physical nor functional evaluation could be performed.Based on the information currently available an assignable cause for this event cannot be determined.
Event or Problem Description
During the coil embolization procedure, it was reported that the main coil prematurely detached outside the aneurysm and the main coil was left in the patient.There was a slight delay to the surgical and the aspirin was provided to the patient as a result of the reported event.No further information is available now.

• Brand Name: TARGET 360 STANDARD 6MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7791902
• Report Number: 3008881809-2018-00353
• Device Sequence Number: 14061747
• Product Code: HCG
• UDI-Device Identifier: 07613252239444
• UDI-Public: 07613252239444
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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,Followup
• Report Date (Section B): 09/19/2018

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: 04/18/2021
• Device Catalogue Number: M0035466300
• Device Lot Number: 20450623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: Required Intervention