MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the coil embolization procedure, resistance was felt while inserting the coil delivery wire in the hub.The coil came back rolling in the hub and main coil was found broken.The procedure was continued with new coil.There were no clinical consequences reported to the patient.
Additional Manufacturer Narrative
Expiration date: added.Manufacturing date: added.The device history record review confirms 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 it is possible that the main coil encountered difficulty while advancing through the microcatheter and later broke due to some procedural factors encountered during use.Also, it has been reported that a non-stryker microcatheter was used for performing the procedure which can also contribute to failure due to potential incompatibility of non-stryker devices as per dfu, however this could not be confirmed.Therefore the an assignable cause of undeterminable is assigned for the investigation.
Event or Problem Description
It was reported that during the coil embolization procedure, resistance was felt while inserting the coil delivery wire in the hub.The coil came back rolling in the hub and main coil was found broken.The procedure was continued with new coil.There were no clinical consequences reported to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7668057
• Report Number: 3008881809-2018-00298
• Device Sequence Number: 11016697
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• Combination Product (Y/N): N
• 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): 08/15/2018

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: 01/31/2021
• Device Catalogue Number: M0035423100
• Device Lot Number: 20243075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1