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

Model Number	M0035423060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labelling or packaging failed to meet its specifications when released.The device was returned within the introducer sheath.Visual and microscopic inspection of the returned device found that proximal contact and delivery wire were bent, likely due to handling damage.In addition, the delivery wire was broken from the main coil.Functional testing could not be performed due to the condition of the returned device.Per additional information, the device was confirmed to be in good condition prior to the procedure, and the dfu was used during the set up and procedure.Based on the information available and analysis of the device, an assignable cause of handling damage was assigned to this investigation.
Event or Problem Description
Analysis of the returned device found that the delivery wire was broken.There was no clinical consequence to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7063776
• Report Number: 3008881809-2017-00495
• Device Sequence Number: 156591
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: (01)04546540675880(17)200531(10)19756421
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093142
• 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): 11/28/2017

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: 05/31/2020
• Device Model Number: M0035423060
• Device Catalogue Number: M0035423060
• Device Lot Number: 19756421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1