MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036123060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the coil delivery wire was kinked/bent and the main coil was noted to be stretched.The coil detached from the delivery wire on removal from the introducer sheath.Blood was also noted in the introducer sheath.' functional testing could not be performed due to the condition of the returned device.In case of this complaint, the coil detached from the delivery wire on removal of the coil from the introducer sheath which indicates partial detachment during the procedure.The blood noted in the introducer sheath indicates insufficient flushes.It is most likely that the main coil stretched and prematurely detached due to lack of continuous flush (intermittent) maintained during the procedure which is against the direction for use (dfu) for this product.As per the 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 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 investigation results and available information an assignable cause of user error was assigned to the as analyzed issue main coil prematurely detached/separated inside patient, as the complaint confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacture and/or expected by the user.
Event or Problem Description
Analysis of the returned device found that the coil was prematurely detached/separated inside patient.No known clinical consequences reported due to this event.

• Brand Name: TARGET XL 360 SOFT 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8962659
• Report Number: 3008881809-2019-00260
• Device Sequence Number: 3147171
• Product Code: HCG
• UDI-Device Identifier: 07613327128277
• UDI-Public: 07613327128277
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• 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
• Report Date (Section B): 09/04/2019

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: 08/08/2021
• Device Catalogue Number: M0036123060
• Device Lot Number: 20743062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1