MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035474100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the coil was advanced in the microcatheter, it detached prematurely inside the microcatheter.The microcatheter was removed along with the coil from the patient.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Manufacturing date  added.Device evaluated by mfg updated.Expiration date - added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned within the microcatheter used during the procedure.Visual inspection of the device revealed that the delivery wire was kinked, likely due to handling.There was blood observed within the microcatheter hub and introducer sheath.The main coil was found to be broken as well.During functional testing, the introducer sheath was flushed and blood was observed to exit.The returned microcatheter was cut and the coil was noted to be jammed and stretched within.The coil was unable to be removed from the microcatheter.The reported event of the coil premature detachment was able to be confirmed based on the information available and analysis of the device.The device was confirmed to be in good condition prior to use.The presence of blood is an indication that continuous flush was not maintained; however, this could not be definitively determined.It is probable that the blood within the microcatheter caused friction within the microcatheter and the subsequent events leading to the reported main coil prematurely detaching within the microcatheter and analyzed coil break.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported and observed damages.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
It was reported that when the coil was advanced in the microcatheter, it detached prematurely inside the microcatheter.The microcatheter was removed along with the coil from the patient.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 4MM 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: 6750066
• Report Number: 3008881809-2017-00224
• Device Sequence Number: 16349189
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: (01)07613252192756(17)200430(10)19680223
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093142
• 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): 11/16/2017

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: 04/30/2020
• Device Model Number: M0035474100
• Device Catalogue Number: M0035474100
• Device Lot Number: 19680223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 11/16/2017
• 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 MICROCATHETER (STRYKER)
• Patient Age: 66 YR