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

Catalog Number	M0036101450
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization of a lienal artery aneurysm, friction was experienced as the coil (subject device) was advanced inside the microcatheter.The coil eventually became jammed at about 4cm form the proximal part of the microcatheter.While continuing to advance the coil further, the delivery wire was bent and the coil was detached at the detachment zone inside the microcatheter.The coil and microcatheter were removed from the patient¿s body as one unit.No impact to the patient was reported.
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 a functional testing could not be performed.Based on information from the complaint, the coil was re-positioned several times.Flush was intermittent.As per the target coil 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.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 available an assignable cause of use error was assigned to this investigation.
Event or Problem Description
It was reported that during coil embolization of a lienal artery aneurysm, friction was experienced as the coil (subject device) was advanced inside the microcatheter.The coil eventually became jammed at about 4cm form the proximal part of the microcatheter.While continuing to advance the coil further, the delivery wire was bent and the coil was detached at the detachment zone inside the microcatheter.The coil and microcatheter were removed from the patient¿s body as one unit.No impact to the patient was reported.

• Brand Name: TARGET XL 360 STANDARD 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: 6156027
• Report Number: 3008881809-2016-00298
• Device Sequence Number: 994513
• Product Code: HCG
• UDI-Device Identifier: 04546540711298
• UDI-Public: (01)04546540711298(17)190331(10)18922281
• 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): 03/01/2017

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: 03/31/2019
• Device Catalogue Number: M0036101450
• Device Lot Number: 18922281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 03/01/2017
• 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: RENEGADE MICROCATHETER (STRYKER)
• Patient Age: 56 YR