MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4 MM X 15 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035434150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil had been repositioned several times when it mechanically detached.The physician removed the coil with a gooseneck snare device.There was no reported clinical consequence to the patient due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Only the main coil was returned.Analysis of the main coil revealed that it had physically detached/separated at the detachment zone and procedural fluid was present on the main coil.In addition the coil was kinked and stretched.No damage was observed to the main coil suture.No other anomalies were observed.A functional test could not be performed as the coil had detached/separated from the delivery wire.Information available indicated that the target coil was confirmed to be in good condition prior to use, the coil was repositioned several times and flus was intermittent.As per the target dfu ¿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 probable that intermittent flush contributed to the reported detachment of the coil in addition to the observed main coil damages.Based on analysis of the device and information available, an assignable cause of use error was assigned to this investigation.
Event or Problem Description
It was reported that the coil had been repositioned several times when it mechanically detached.The physician removed the coil with a gooseneck snare device.There was no reported clinical consequence to the patient due to this event.

• Brand Name: TARGET HELICAL ULTRA 4 MM X 15 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6001574
• Report Number: 3008881809-2016-00201
• Device Sequence Number: 10961098
• Product Code: HCG
• UDI-Device Identifier: 04546540676122
• UDI-Public: (01)04546540676122(17)190531(10)19064810
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: M0035434150
• Device Lot Number: 19064810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 03/21/2017
• 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: EXCELSIOR 1018 (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention