MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 10MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035461030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available.
Event or Problem Description
It was reported that during the procedure the subject coil prematurely detached inside the microcatheter.The prematurely detached coil and the microcatheter were successfully removed from the patient as one unit.The same microcatheter was used again to finish the procedure.There was no clinical consequence to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available during the procedure the subject coil prematurely detached inside the microcatheter.Review and analysis of all available information failed to indicate an assignable cause or probable assignable cause for the reported event.Based on the information available the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that during the procedure the subject coil prematurely detached inside the microcatheter.The prematurely detached coil and the microcatheter were successfully removed from the patient as one unit.The same microcatheter was used again to finish the procedure.There was no clinical consequence to the patient due to the reported event.

• Brand Name: TARGET 360 STANDARD 10MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6003886
• Report Number: 3008881809-2016-00204
• Device Sequence Number: 793679
• Product Code: HCG
• UDI-Device Identifier: 04546540676139
• UDI-Public: (01)04546540676139(17)190131(10)18799671
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 01/11/2017

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: 01/31/2019
• Device Catalogue Number: M0035461030
• Device Lot Number: 18799671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 01/11/2017
• 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: BENCHMARK 071 CATHETER (PENUMBRA INC.); EXCELSIOR SL-10 MICROCATHETER (STRYKER)