MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the 1 of 2 reports.The subject device is not available.
Event or Problem Description
It was reported that during coil embolization procedure, the subject coil detached in the microcatheter inside the patient.The customer did not maintain continuous flush as recommended per dfu.The physician did not make any attempts to detach the coil using the detachment system.The physician removed the detached coil to continue with the procedure.A snare device was not used when the subject coil was removed.Similar event occurred to another coil used in the procedure.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as functional testing could not be performed.Based on the additional information provided it is most likely that the main coil broke due to a lack of continuous flush during the procedure.Lack of continuous flush can result in friction issues causing the coil to break.As per the device directions for use (dfu): "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".Because the device dfu contains specific instructions regarding use of continuous flush, which was omitted, an assignable cause of use error was assigned for the reported event 'nv ¿ main coil broken/fractured '.It was also reported that a non-stryker microcatheter was used during this procedure which may also contributed to the reported failure due to potential incompatibility of a non-stryker device with the target detachable coil system, the use of another manufacturer¿s device(s) with the target detachable coil system is not recommended as per dfu.
Event or Problem Description
It was reported that during coil embolization procedure, the subject coil detached in the microcatheter inside the patient.The customer did not maintain continuous flush as recommended per dfu.The physician did not make any attempts to detach the coil using the detachment system.The physician removed the detached coil to continue with the procedure.A snare device was not used when the subject coil was removed.Similar event occurred to another coil used in the procedure.No clinical consequences reported to the patient.

• Brand Name: TARGET XXL 360 14MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7526812
• Report Number: 3008881809-2018-00233
• Device Sequence Number: 16550873
• Product Code: HCG
• UDI-Device Identifier: 07613327128383
• UDI-Public: (01)07613327128383(17)200731(10)19901502
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 07/25/2018

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: 07/31/2020
• Device Model Number: M0036181450
• Device Catalogue Number: M0036181450
• Device Lot Number: 19901502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1