MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101240
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil embolization procedure physician retracted the subject coil to do the repositioning and the coil prematurely detached inside the microcatheter.The all pieces of the coil (main coil and pusher wire) were retrieved with the guidecatheter and microcatheter as a whole unit.There was no clinical consequence to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual and microscopic testing revealed that the delivery wire and main coil were kinked.The returned main coil was found physically detached from the delivery wire with the traces of dried blood on the junction.A functional test could not be performed as the main coil was separated from the delivery wire.Dried blood was noted on the main coil which is indicative of insufficient flush.Based on analysis and additional information, no anomalies were found prior to use.Information available indicated that the device was not flushed properly during procedure.According to the target device for use "warning: in order to achieve optimal performance of the target detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between the femoral sheath and guiding catheter, the 2-tip microcatheter and guiding catheters, and the 2 tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil".It is likely that insufficient flush may have contributed to the resistance which may have caused the main coil jamming, kinking and physical separation at the detachment zone during the device manipulation.Therefore, an assignable cause of use error will be assigned to the event.
Event or Problem Description
It was reported that during coil embolization procedure physician retracted the subject coil to do the repositioning and the coil prematurely detached inside the microcatheter.The all pieces of the coil (main coil and pusher wire) were retrieved with the guidecatheter and microcatheter as a whole unit.There was no clinical consequence to the patient due to the reported event.

• Brand Name: TARGET XL 360 STANDARD 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5704330
• Report Number: 3008881809-2016-00024
• Device Sequence Number: 13506623
• Product Code: HCG
• UDI-Device Identifier: 04546540711281
• UDI-Public: (01)04546540711281(17)180930(10)18595607
• Combination Product (Y/N): N
• PMA/510(K) Number: K123377
• 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): 05/11/2016

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: 09/30/2018
• Device Catalogue Number: M0036101240
• Device Lot Number: 18595607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 10/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1