MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035476150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that the delivery wire was found to be separated.In addition, the main coil was found to be kinked and stretched likely due to procedural factors.Following the functional test, the friction was encountered.There was dried blood found within the introducer sheath which may indicate flush was not maintained during the procedure.It is probable that the delivery wire break is due to handling of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use, thus limiting the performance of the device.Therefore; an assignable cause of cause traced to component failure" will be assigned to the analyzed delivery wire break.
Event or Problem Description
Analysis of the device revealed that the coil delivery wire was broken.There was no clinical consequence to the patient due to this event.

• Brand Name: TARGET 360 SOFT 6MM X15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7783613
• Report Number: 3008881809-2018-00343
• Device Sequence Number: 1392672
• Product Code: HCG
• UDI-Device Identifier: 04546540676535
• UDI-Public: 04546540676535
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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: M0035476150
• Device Lot Number: 20223010
• 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: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1