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

Model Number	M0036101240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
The physician failed to flush and the coil broke off in the microcatheter; it was reported the coil was in the patient's body.No additional information is available.
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 neither physical nor functional evaluation could be performed.Based on the information currently available an assignable cause for this event cannot be determined.
Event or Problem Description
The physician failed to flush and the coil broke off in the microcatheter; it was reported the coil was in the patient's body.No additional information is available.

• Brand Name: TARGET XL 360 STANDARD 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: 7519148
• Report Number: 3008881809-2018-00229
• Device Sequence Number: 16490144
• Product Code: HCG
• UDI-Device Identifier: 04546540711281
• UDI-Public: (01)04546540711281(17)201130(10)20154881
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: M0036101240
• Device Catalogue Number: M0036101240
• Device Lot Number: 20154881
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/18/2018
• 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: MICROCTHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other; Required Intervention