MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422540
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was disposed of at the hospital.
Event or Problem Description
It was reported that during the coil embolization procedure resistance was encountered when the subject coil was advanced through the microcatheter's shaft.The physician attempted to retract the coil and upon removal the main coil had prematurely detached in the hub of the microcatheter.The detached coil was removed from the hub and the procedure successfully completed with no patient impact.
Additional Manufacturer Narrative
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.Based on the information available the device was confirmed to be in good condition prior to use.Based on the information currently available, the cause for the reported issue cannot be determined.
Event or Problem Description
It was reported that during the coil embolization procedure resistance was encountered when the subject coil was advanced through the microcatheter's shaft.The physician attempted to retract the coil and upon removal the main coil had prematurely detached in the hub of the microcatheter.The detached coil was removed from the hub and the procedure successfully completed with no patient impact.

• Brand Name: TARGET 360 ULTRA 2.5MM 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: 5710309
• Report Number: 3008881809-2016-00028
• Device Sequence Number: 207999
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: (01)04546540675866(17)181031(10)18638782
• Combination Product (Y/N): N
• 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): 05/17/2016

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: 10/31/2018
• Device Catalogue Number: M0035422540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2016
• Supplement Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1