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

Catalog Number	M0035431520
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was disposed at the facility.
Event or Problem Description
It was reported that the coil was placed into the aneurysm and detachment was attempted.The coil did not detach and the physician started to withdraw the pusher wire under fluoroscopy; however, the coil spontaneously detached while withdrawing the pusher wire.There was no clinical consequence to the patient.No further details were provided.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Information available indicated that the device was confirmed to be in good condition prior to use.Therefore a cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that the coil was placed into the aneurysm and detachment was attempted.The coil did not detach and the physician started to withdraw the pusher wire under fluoroscopy; however, the coil spontaneously detached while withdrawing the pusher wire.There was no clinical consequence to the patient.No further details were provided.

• Brand Name: TARGET HELICAL 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: 5779094
• Report Number: 3008881809-2016-00072
• Device Sequence Number: 10895099
• Product Code: HCG
• UDI-Device Identifier: 04546540698032
• UDI-Public: (01)04546540698032(17)180731(10)18495421
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2016

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: 07/31/2018
• Device Catalogue Number: M0035431520
• Device Lot Number: 18495421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2016
• Supplement Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1