MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036124080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
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 subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Additional information provided by the customer indicated no anomalies noted to the device during preparation/prior to use and continuous flush was maintained.In the case of this complaint it is most likely that the main coil detached prematurely inside the patient due to the patient anatomy, handling issues, and procedural factors encountered during use.However, this cannot be confirmed.Therefore, based on the information currently available the exact cause for the reported event cannot be determined.The subject device is not available.
Event or Problem Description
During the coil embolization procedure, it was reported that the coil (subject device) could not be placed well.So the physician decided to remove it, however, the main coil was prematurely detached in the microcatheter during removal.Then the coil was removed together with the microcatheter.The procedure was completed successfully after replacing the coil.No clinical consequences reported to the patient.

• Brand Name: TARGET XL 360 SOFT 4MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9416143
• Report Number: 3008881809-2019-00374
• Device Sequence Number: 16276987
• Product Code: HCG
• UDI-Device Identifier: 07613327128390
• UDI-Public: 07613327128390
• 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): 12/05/2019

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: 10/31/2020
• Device Catalogue Number: M0036124080
• Device Lot Number: 20060528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/05/2019
• 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 MICROCATHETER (STRYKER)
• Patient Age: 68 YR