MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 6MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180640
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.During the analysis of the returned device, it was revealed that the coil delivery wire was kinked due to handling damage.In addition, the main coil was stretched and was prematurely detached.The functioning test could not be performed as the coil was detached.Additional information provided by the customer indicated that continuous flush was not maintained throughout the procedure.Per the 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".In the case of this complaint it is probable that the main coil difficulty inserting was noted during the procedure due to insufficient flush during the procedure.Based on the available information and the investigation results, a probable cause of user error will be assigned to the reported main coil difficulty inserting and analysed main coil stretched and main coil prematurely detached/separated inside patient as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
During the analysis of the returned device, it was revealed that the main coil prematurely detached inside patient.No clinical consequences reported to the patient.

• Brand Name: TARGET XXL 360 6MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9639322
• Report Number: 3008881809-2020-00023
• Device Sequence Number: 2668347
• Product Code: HCG
• UDI-Device Identifier: 07613327466409
• UDI-Public: 07613327466409
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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
• Report Date (Section B): 01/28/2020

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: 07/08/2022
• Device Model Number: M0036180640
• Device Catalogue Number: M0036180640
• Device Lot Number: 21579541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1