MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
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.Analysis of the returned device found the proximal contact and delivery wire were bent, likely due to handling, and the main coil was broken.The reported device difficulty inserting was confirmed during analysis based on the damage to the returned device.Additional information provided confirmed the device was in good condition after unpacking and was prepared per device directions for use (dfu).It is probable the device was damaged during the procedure, resulting in the reported difficulty inserting and the subsequent coil break.As such, an assignable cause of operational context was assigned to this investigation.
Event or Problem Description
Analysis of the returned device found that the coil was broken.There was no clinical consequence to the patient due to this event.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7555512
• Report Number: 3008881809-2018-00247
• Device Sequence Number: 16187614
• Product Code: HCG
• UDI-Device Identifier: 07613327313949
• UDI-Public: 07613327313949
• 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): 05/30/2018

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: M0035421540
• Device Lot Number: 19881253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 05/30/2018
• 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: 68