MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035477150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil prematurely detached inside the patient.Therefore, the physician used the snare to remove the detached coil.No further information is available for now.
Additional Manufacturer Narrative
"initial reporter name", "initial reporter first name" and "initial reporter last name": updated based on additional information received.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.In the case of this complaint friction was encountered inside a microcatheter during the procedure and the coil detached prematurely most likely during attempted withdrawal of the coil from the catheter after unsuccessful advancement.This however cannot be conclusively determined.Therefore, the exact cause for the reported event could not be determined.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil prematurely detached inside the patient.Therefore, the physician used the snare to remove the detached coil.No further information is available for now.

• Brand Name: TARGET 360 SOFT 7MM 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: 8933446
• Report Number: 3008881809-2019-00250
• Device Sequence Number: 2207037
• Product Code: HCG
• UDI-Device Identifier: 04546540676566
• UDI-Public: 04546540676566
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/14/2019

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: 01/01/2022
• Device Catalogue Number: M0035477150
• Device Lot Number: 21110310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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: MICROCATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention