MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the coil (subject device) prematurely detached inside the microcatheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device found that main coil was partially deployed electrolytically.Functional testing could not be performed as the main coil was not returned with the device.The reported event is covered in the device directions for use (dfu), as well as 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.It is likely procedural and/or anatomical factors during use limited the device's performance, therefore a cause of procedural factors will be assigned to the reported issue.
Event or Problem Description
It was reported that the coil (subject device) prematurely detached inside the microcatheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 2.5 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8452604
• Report Number: 3008881809-2019-00080
• Device Sequence Number: 10812496
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: 07613252600305
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 05/27/2019

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: 10/22/2021
• Device Catalogue Number: M0035442540
• Device Lot Number: 20944034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/27/2019
• 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 MICROCATHETER (STRYKER); EXCELSIOR MICROCATHETER (STRYKER)