MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035473060
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during coil embolization procedure the coil prematurely separated at the detachment zone.The physician safely removed the coil from the patient's body with a retrieval device without clinical consequence to the patient.
Additional Manufacturer Narrative
Expiration date/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 was prepared ad per the device direction for use (dfu).Based on the information currently available the exact cause for the reported issue cannot be determined.
Event or Problem Description
It was reported that during coil embolization procedure the coil prematurely separated at the detachment zone.The physician safely removed the coil from the patient's body with a retrieval device without clinical consequence to the patient.

• Brand Name: TARGET 360 SOFT 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6119355
• Report Number: 3008881809-2016-00273
• Device Sequence Number: 52995
• Product Code: HCG
• UDI-Device Identifier: 04546540676429
• UDI-Public: (01)04546540676429(17)190531(10)19079427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: M0035473060
• Device Lot Number: 19079427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 02/06/2017
• 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 SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 98