MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that the coil (subject device) was prematurely separated from the delivery wire at the detachment zone inside the rotating hemostatic valve (rhv) while being retracted and re-sheathed due to the resistance encountered during the advancement of the coil through the microcatheter shaft.There was no clinical consequence to the patient due to the reported event.
Additional Manufacturer Narrative
Expiration date/manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available the exact cause for the reported issue cannot be determined.
Event or Problem Description
It was reported that the coil (subject device) was prematurely separated from the delivery wire at the detachment zone inside the rotating hemostatic valve (rhv) while being retracted and re-sheathed due to the resistance encountered during the advancement of the coil through the microcatheter shaft.There was no clinical consequence to the patient due to the reported event.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6309568
• Report Number: 3008881809-2017-00034
• Device Sequence Number: 578208
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: (01)07613252192756(17)191031(10)19363920
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K102672
• 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,Followup
• Report Date (Section B): 04/27/2017

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: 10/31/2019
• Device Catalogue Number: M0035474100
• Device Lot Number: 19363920
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER ECHELON
• Patient Age: 47 YR