MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421530
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during the procedure, the subject coil failed to detach.The physician re-inserted the subject coil in the micro catheter, but it pre-maturely detached in the micro catheter.The physician completed the procedure successfully without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, the subject coil failed to detach.The physician re-inserted the subject coil in the micro catheter, but it pre-maturely detached in the micro catheter.The physician completed the procedure successfully without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, 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.Additional information provided by the customer indicated that preparation/set-up was performed as per the dfu and continuous flush was maintained for the duration of the procedure.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable will be assigned to the reported complaint.

• Brand Name: TARGET 360 NANO 1.5MM X 3CM
• 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: 9996944
• Report Number: 3008881809-2020-00119
• Device Sequence Number: 4483327
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: 04546540697943
• 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): 06/19/2020

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: 11/02/2022
• Device Model Number: M0035421530
• Device Catalogue Number: M0035421530
• Device Lot Number: 21891024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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: MICRO CATHETER (UNKNOWN MANUFACTURER)