MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036106200
Medical Device Problem Codes	Unintended Movement (3026); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains in patient.
Event or Problem Description
During the coil embolization procedure, it was reported that the second coil was prematurely detached in the microcatheter when the physician tried to reposition the coil by re-sheathing it into the microcatheter.And part of the main coil was protruded out of the aneurysm.Therefore, other coils were implanted to push the coil inside and plavix was administrated to the patient.No clinical consequences reported to the patient.
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.Information available indicated that the device was confirmed to be in good condition prior to use and the device was prepared as per the dfu (direction for use).Based on the information currently available the exact cause for the reported event cannot be determined.
Event or Problem Description
During the coil embolization procedure, it was reported that the second coil was prematurely detached in the microcatheter when the physician tried to reposition the coil by re-sheathing it into the microcatheter.And part of the main coil was protruded out of the aneurysm.Therefore, other coils were implanted to push the coil inside and plavix was administrated to the patient.No clinical consequences reported to the patient.

• Brand Name: TARGET XL 360 STANDARD 6MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8108554
• Report Number: 3008881809-2018-00499
• Device Sequence Number: 1961613
• Product Code: HCG
• UDI-Device Identifier: 07613327004779
• UDI-Public: 07613327004779
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: M0036106200
• Device Lot Number: 19998325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR