MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101450
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual and microscopic testing revealed that the delivery wire was kinked, main coil was severely stretched, broken, and the main coil suture was damaged.The main coil was found physically separated at the detachment zone and traces of dried blood were observed.A functional test could not be performed as the main coil was separated from the delivery wire.Information available indicated that the device was confirmed to in good condition prior to use.In addition, information obtained indicated that the device was not flushed properly during procedure.According to the target device for use "warning: in order to achieve optimal performance of the target detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2 tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil".It is likely that insufficient flush may have caused the resistance during the coil manipulation resulting in the main coil kinking, stretching, brake and physical separation at the detachment zone during clinical procedure.Therefore, an assignable cause of use error will be assigned to the event.
Event or Problem Description
Analysis of the returned coil revealed that the main col was broken at multiple locations and appeared to have prematurely separated physically at the detachment zone.There were no reported patient consequences.

• Brand Name: TARGET XL 360 STANDARD 14MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6067908
• Report Number: 3008881809-2016-00238
• Device Sequence Number: 422958
• Product Code: HCG
• UDI-Device Identifier: 04546540711298
• UDI-Public: (01)04546540711298(17)180930(10)18596388
• 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
• Report Date (Section B): 05/11/2016

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: 09/30/2018
• Device Catalogue Number: M0036101450
• Device Lot Number: 18596388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2016
• Initial Report FDA Received Date: 10/31/2016
• 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: RENEGADE MICROCATHETER (STRYKER)