MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable.
Event or Problem Description
It was reported that the subject device prematurely deployed inside the catheter.Per physician¿s opinion may have been caused by friction inside the catheter.Additionally,the friction was observed while advancing the subject device through stent and the subject device deployed when it was pulled back.The subject device and the microcatheter were safely removed from the patient as one unit and there was no clinical consequence to the patient due to the reported event.
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.Based on the information currently available an assignable cause for this event cannot be determined.
Event or Problem Description
It was reported that the subject device prematurely deployed inside the catheter.Per physician¿s opinion may have been caused by friction inside the catheter.Additionally,the friction was observed while advancing the subject device through stent and the subject device deployed when it was pulled back.The subject device and the microcatheter were safely removed from the patient as one unit and there was no clinical consequence to the patient due to the reported event.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7987197
• Report Number: 3008881809-2018-00458
• Device Sequence Number: 165604
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: 04546540711533
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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): 11/12/2018

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: 11/30/2020
• Device Catalogue Number: M0036121240
• Device Lot Number: 20140363
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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: ATLAS STENT (STRYKER); MICOCATHETER (PHENOM)