MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
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, the coil failed to detach.The operator tried to use another detachment device to detach it but failed.So the operator withdrew the coil and found tip of the coil dropped in microcatheter.The procedure was completed using other devices.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The analysis of the device revealed that the main coil was not returned in full, it was found to be broken fractured on the wind.In additional the delivery wire was found kinked, likely due to handling.During functional testing, there was friction noted when advancing the device through the introducer sheath which was caused by the damage to the delivery wire.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the device direction for use(dfu), but performance was limited due to procedural or anatomical factors during use.Therefore an assignable cause of procedural factors was given to the reported coil break.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil failed to detach.The operator tried to use another detachment device to detach it but failed.So the operator withdrew the coil and found tip of the coil dropped in microcatheter.The procedure was completed using other devices.No clinical consequences were reported to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8238541
• Report Number: 3008881809-2019-00018
• Device Sequence Number: 2125200
• Product Code: HCG
• UDI-Device Identifier: 04546540675897
• UDI-Public: 04546540675897
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 02/15/2019

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: 06/20/2021
• Device Catalogue Number: M0035423080
• Device Lot Number: 20675280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/15/2019
• 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: SL-10 MICROCATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Age: 43 YR