MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the coil was advanced in the microcatheter, the coil experienced resistance and detached prematurely.The coil was retrieved along with the microcatheter from the patient's anatomy without clinical consequences.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned without the introducer sheath and detached from the delivery wire.Visual inspection of the device revealed that the delivery wire and proximal contact were kinked, likely due to handling.The main coil was observed to be stretched, kinked and tangled.In addition, the detachment zone was inspected and it was confirmed that the coil had detached due to a physical break at the detachment zone.Functional testing could not be performed as the coil was detached from the delivery wire and the introducer sheath was not returned.The device was confirmed to be in good condition prior to use.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 kink, stretch, tangle and physical break of the main coil from the detachment zone.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, the coil experienced resistance and detached prematurely.The coil was retrieved along with the microcatheter from the patient's anatomy without clinical consequences.

• Brand Name: TARGET XL 360 STANDARD 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6444281
• Report Number: 3008881809-2017-00095
• Device Sequence Number: 16288383
• Product Code: HCG
• UDI-Device Identifier: 04546540711274
• UDI-Public: (01)04546540711274(17)181130(10)18731440
• Combination Product (Y/N): N
• PMA/510(K) Number: K123377
• 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): 08/29/2017

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: 11/30/2018
• Device Model Number: M0036101040
• Device Catalogue Number: M0036101040
• Device Lot Number: 18731440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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)