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

Model Number	M0035423100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The device was returned in the introducer sheath and jammed in a xt 27 microcatheter.Visual and microscopic inspection of the device found that the proximal contact and delivery wire were kinked, likely due to handling.In addition, the coil was found to be kinked, stretched and appeared to being mechanically separated from the delivery wire.Additional information available indicated that the coil could not be advanced through the microcatheter during procedure.As per the target dfu: ¿target detachable coils are compatible with stryker neurovascular 2-tip marker microcatheters (min.Internal diameter 0.41 mm [0.016 in], max.Internal diameter 0.48 mm [0.019 in]).¿ the xt 27 microcatheter is a single lumen 0.027 in id (inner diameter) device.The target coils are not compatible with xt 27 microcatheters.The lumen of the xt 27 microcatheter is too large for target coil which could easily wrapped around itself inside the lumen as it has too much space, causing friction and probably resulting in the reported event and main coil damages observed.Therefore, based on the information available and analysis results an assignable cause of use error was assigned to this event.
Event or Problem Description
Analysis of the returned device revealed that the coil was detached from the delivery wire.There was no clinical consequence to the patient due to this event.

• 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: 7043455
• Report Number: 3008881809-2017-00482
• Device Sequence Number: 10997793
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: (01)04546540675903(17)191031(10)19375463
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112385
• 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): 11/17/2017

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 Model Number: M0035423100
• Device Catalogue Number: M0035423100
• Device Lot Number: 19375463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1