MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3.5 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443560
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil prematurely detached inside the microcatheter and possibly fractured from the aneurysm.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that the coil prematurely detached inside the microcatheter and possibly fractured from the aneurysm.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the coil delivery wire was kinked likely due to handling.The main coil was not returned for analysis and the detachment zone appeared to be electrolytically detached thus confirming the reported event.It is most likely that anatomical or procedural factors resulted in the target delivery wire kink and eventually prematurely detached when trying to remove from the aneurysm;therefore, an assignable cause of procedural factors has been assigned to this investigation.

• Brand Name: TARGET 360 NANO 3.5 MM X 6 CM
• 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: 9360162
• Report Number: 3008881809-2019-00357
• Device Sequence Number: 19374829
• Product Code: HCG
• UDI-Device Identifier: 07613252600343
• UDI-Public: 07613252600343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 06/13/2021
• Device Model Number: M0035443560
• Device Catalogue Number: M0035443560
• Device Lot Number: 20600527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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)