MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed that the coil delivery wire was kinked, likely while handling the device either during the preparation for the procedure or during the clinical procedure.Additionally, the main coil was kinked and broken which would have contributed to friction noted during the procedure.Functional testing was not performed as the delivery wire stuck inside the introducer sheath.Based on the investigation results and available information, an assignable cause of procedural factors - cause traced to component failure will be assigned to this investigation.The issue is associated with a product that meets stryker design and manufacture specifications and was used according to the device directions for use (dfu) but due to procedural and/or anatomical factors encountered during use, the device performance was limited.
Event or Problem Description
Analysis of the device revealed that the subject coil delivery wire was broken.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 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: 8026562
• Report Number: 3008881809-2018-00470
• Device Sequence Number: 1382398
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Report Date (Section B): 10/31/2018

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: 06/30/2020
• Device Catalogue Number: M0035421520
• Device Lot Number: 19880667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 58