MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available.
Event or Problem Description
The physician was unable to detached the coil after several detachment attempts; therefore, the physician decided to remove it.It was reported that as the coil was being removed, it prematurely detached, resulting in part of the coil protruding into the parent vessel.There were no reported clinical consequences to the patient.No further details were provided.
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.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.An assignable cause of undeterminable will be assigned to the event as the review and analysis of all available information was unable to indicate an assignable cause or probable assignable cause.
Event or Problem Description
The physician was unable to detached the coil after several detachment attempts; therefore, the physician decided to remove it.It was reported that as the coil was being removed, it prematurely detached, resulting in part of the coil protruding into the parent vessel.There were no reported clinical consequences to the patient.No further details were provided.

• Brand Name: TARGET 360 ULTRA 3MM 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: 6001613
• Report Number: 3008881809-2016-00202
• Device Sequence Number: 77576
• Product Code: HCG
• UDI-Device Identifier: 04546540675958
• UDI-Public: (01)04546540675958(17)190630(10)19100819
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K112385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2017

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: 06/30/2019
• Device Catalogue Number: M0035423100
• Device Lot Number: 19100819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR