MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was broken, stretched and the main coil suture was damaged.In addition, the coil delivery wire was kinked due to handling.The functioning test could not be performed due to the condition of the returned device.Additional information indicated that the coil was confirmed to be in good condition prior to use and it was prepared as per dfu (direction for use).It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered during use.Therefore, an assignable cause of procedural factors will be assigned to the analyzed defects on the main coil and the suture.The issue is associated with a product that meets the design and manufacture specifications and was used according to the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
During the analysis of the returned device, it was revealed that the main coil was broken.No clinical consequences reported to the patient.

• Brand Name: TARGET 360 NANO 1MM 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: 7787175
• Report Number: 3008881809-2018-00349
• Device Sequence Number: 181832
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: 01/31/2021
• Device Catalogue Number: M0035421020
• Device Lot Number: 20267740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1