MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 1CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431010
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device revealed that the proximal contact and delivery wire were kinked likely due to handling.The main coil was detached and was not returned.Analysis of the delivery wire detachment zone revealed that the detachment of the coil appeared to have occurred via electrolysis.Information available indicated that the coil was confirmed to be in good condition prior to use; however, that it could not be detached during procedure.As the main coil was not returned and only the delivery wire, it cannot be determined when during the procedure the coil detached and further information is not available.Based on the information currently available the exact cause for the coil detachment cannot be determined.
Event or Problem Description
Analysis of the returned device revealed that the main coil had detached from the delivery wire.There were no patient clinical consequences reported.

• Brand Name: TARGET HELICAL NANO 1MM X 1CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6730365
• Report Number: 3008881809-2017-00218
• Device Sequence Number: 18995845
• Product Code: HCG
• UDI-Device Identifier: 04546540700216
• UDI-Public: (01)04546540700216(17)190731(10)19202622
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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
• Report Date (Section B): 07/20/2017

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: 07/31/2019
• Device Model Number: M0035431010
• Device Catalogue Number: M0035431010
• Device Lot Number: 19202622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1