MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the coil embolization procedure, it was reported that the 8th coil (subject device) could not be detached.Therefore, the physician decided to remove the coil.However, the coil was mechanically detached in the microcatheter during removal.So the physician used a guidewire to push the coil into the aneurysm.After that, seven coils were deployed in the aneurysm and the procedure was completed successfully.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.During the analysis of the returned device, it was revealed that the main coil appears to have detached electronically based on the inspection on the delivery wire detachment zone.The functioning test could not be performed due to the condition of the returned device.Additional information indicated that the coil was confirmed to be in good condition after unpacking and preparation.There is no indication of a use error.Therefore, an assignable cause of ¿cause traced to component failure" will be assigned to the reported event, as the issue is associated with a product that meets the design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
During the coil embolization procedure, it was reported that the 8th coil (subject device) could not be detached.Therefore, the physician decided to remove the coil.However, the coil was mechanically detached in the microcatheter during removal.So the physician used a guidewire to push the coil into the aneurysm.After that, seven coils were deployed in the aneurysm and the procedure was completed successfully.No clinical consequences reported to the patient.

• Brand Name: TARGET 360 ULTRA 3MM 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: 8171680
• Report Number: 3008881809-2018-00531
• Device Sequence Number: 13812180
• Product Code: HCG
• UDI-Device Identifier: 04546540675897
• UDI-Public: 04546540675897
• 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,Followup
• Report Date (Section B): 01/29/2019

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: 07/17/2021
• Device Catalogue Number: M0035423080
• Device Lot Number: 20737846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR