MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035443060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The main coil was not returned.Analysis revealed that the coil had broken off from the delivery wire.There were no anomalies noted to the delivery wire or the introducer sheath.Functional testing could not be performed due to the condition of the returned device.Information available, indicated that device was confirmed to be in good condition prior to use.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
Analysis of the returned coil revealed that it was broken off from the delivery wire.No consequences to the patient were reported.

• Brand Name: TARGET 360 NANO 3 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6152107
• Report Number: 3008881809-2016-00295
• Device Sequence Number: 11132266
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: (01)07613252600329(17)181130(10)18708693
• 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): 07/05/2016

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: 11/30/2018
• Device Catalogue Number: M0035443060
• Device Lot Number: 18708693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2016
• Initial Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR MICROCATHETER (STRYKER)