MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 18MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181850
Medical Device Problem Codes	Expulsion (2933); Unintended Movement (3026); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the subject coil had prematurely detached during use.It was also identified that the subject coil appeared protruding and was subsequently fixed subcutaneously by the physician.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.In the case of this complaint, it is most likely that the device encountered difficulties while inserting and hence prematurely detached due to no flush maintained during the procedure, as per dfu maintaining continuous flush throughout the procedure is a critical requirement as lack of it can lead to friction or other related difficulties.An assignable cause of ¿user error¿ will be assigned to reported events, as the investigation confirmed 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
It was reported that during the procedure the subject coil had prematurely detached during use.It was also identified that the subject coil appeared protruding and was subsequently fixed subcutaneously by the physician.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 18MM X 50CM
• 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: 9942072
• Report Number: 3008881809-2020-00093
• Device Sequence Number: 2916748
• Product Code: HCG
• UDI-Device Identifier: 07613327128413
• UDI-Public: 07613327128413
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 09/23/2022
• Device Model Number: M0036181850
• Device Catalogue Number: M0036181850
• Device Lot Number: 21766117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1