MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL HELICAL 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036115150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports filed for each of the coils that detached mechanically.The subject device is not available.
Event or Problem Description
It was reported that during the repositioning of the coils in the aneurysm, each detach mechanically at the detachment zone.Each of the coils was respectively removed together with the microcatheter every time without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms 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.Information available indicated that the device was confirmed to be in good condition prior to use.Additionally, the event description indicated that the microcatheter (terumo (id: 0.021inch)) was used in the procedure which according to the device directions for use (dfu) was not recommended for this device.The target dfu states "target detachable coils are compatible with stryker neurovascular 2-tip marker microcatheter¿s (min.Internal diameter 0.41 mm [0.016 in], max.Internal diameter 0.48 mm [0.019 in])".Information from the complaint indicated that insufficient flush was used during the procedure which was also against the dfu which states "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".Based on the information currently available, a cause of use error was assigned to this event.
Event or Problem Description
It was reported that during the repositioning of the coils in the aneurysm, each detach mechanically at the detachment zone.Each of the coils was respectively removed together with the microcatheter every time without clinical consequences to the patient.

• Brand Name: TARGET XL HELICAL 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6117091
• Report Number: 3008881809-2016-00270
• Device Sequence Number: 734914
• Product Code: HCG
• UDI-Device Identifier: 07613327004571
• UDI-Public: (01)07613327004571(17)190131(10)18841500
• 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): 02/06/2017

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: M0036115150
• Device Lot Number: 18841500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 02/06/2017
• 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: MICROCATHETER (TERUMO)