MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that when the coil was removed into the introducer sheath, the coil detached prematurely inside the microcatheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Manufacturing date ¿ added.Device evaluated by mfg ¿updated.Summary attached - updated.Expiration date - added.Product available to stryker ¿ updated.Returned to manufacturer on ¿updated.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the delivery wire was kinked/bent most likely due to the handling of the device.The main coil was not returned for analysis and the main coil was found to be detached due to a physical break at the detachment zone.There was procedural fluid was noted on the device as well.Functional testing could not be performed due to the damaged condition of the returned device.Information available indicated that continuous flush was not maintained during the procedure.It is likely that insufficient flush contributed to the damage noted to the device and to the reported issue.As per the device direction 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 a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) 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 event.
Event or Problem Description
It was reported that when the coil was removed into the introducer sheath, the coil detached prematurely inside the microcatheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 5MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7146968
• Report Number: 3008881809-2017-00536
• Device Sequence Number: 966196
• Product Code: HCG
• UDI-Device Identifier: 07613327128314
• UDI-Public: (01)07613327128314(17)190228(10)18859480
• 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): 02/26/2018

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: 02/28/2019
• Device Model Number: M0036125100
• Device Catalogue Number: M0036125100
• Device Lot Number: 18859480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/26/2017
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR