MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL HELICAL 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036115150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the 2 of 2 reports.The subject device is not available.
Event or Problem Description
During the coil embolization procedure, it was reported that the resistance was felt when advancing the subject coil in the microcatheter.So the physician removed the coil and the coil was prematurely detached in the microcatheter.Then the detached coil was removed together with the microcatheter.The same event also happened to another coil used in the procedure.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
Expiration date: added.Manufacturing date: added.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.Information available indicated that the device was confirmed to be in good condition prior to use and the device was prepared as per the dfu.Based on the information currently available the exact cause for the reported main coil prematurely detached inside patient cannot be determined.
Event or Problem Description
During the coil embolization procedure, it was reported that the resistance was felt when advancing the subject coil in the microcatheter.So the physician removed the coil and the coil was prematurely detached in the microcatheter.Then the detached coil was removed together with the microcatheter.The same event also happened to another coil used in the procedure.No clinical consequences reported to the patient.

• Brand Name: TARGET XL HELICAL 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7127829
• Report Number: 3008881809-2017-00526
• Device Sequence Number: 11129446
• Product Code: HCG
• UDI-Device Identifier: 07613327004571
• UDI-Public: (01)07613327004571(17)181031(10)18655522
• Combination Product (Y/N): N
• PMA/510(K) Number: K123377
• 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): 01/15/2018

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: 10/31/2018
• Device Model Number: M0036115150
• Device Catalogue Number: M0036115150
• Device Lot Number: 18655522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/15/2018
• 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: SL-10 MICROCATHETER (STRYKER)
• Patient Age: 54 YR