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

Catalog Number	M0036121450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during aneurysm coiling embolization, only a portion of the coil could exit from the microcatheter and into the aneurysm.The physician was unable to advance or retract the coil and during an attempt to remove it, the coil broke.The proximal section of the coil was inside the microcatheter and the distal segment was inside the aneurysm.The physician used a gooseneck snare device "to catch the coil inside the microcatheter" and cut the microcatheter to remove the coil and then remove the microcatheter from the patient's body.The physician continue the procedure with another coil and microcatheter.There was no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the device revealed that the main coil was prematurely detached/separated via a physical break from the delivery wire thus confirming the reported issue.The delivery wire was found kinked/bent likely due to handling during use.Functional testing of the device could not be performed due to its returned condition.Information available indicated that the device was confirmed to be in good condition prior to use and that continuous flush was not maintained.As per the dfu "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: the femoral sheath and guiding catheter; the 2-tip microcatheter and guiding catheters and; 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 contributed to the coil separating and/or breaking off from the delivery wire.Therefore, an assignable cause of use error was assigned to this as reported and confirmed break.
Event or Problem Description
It was reported that during aneurysm coiling embolization, only a portion of the coil could exit from the microcatheter and into the aneurysm.The physician was unable to advance or retract the coil and during an attempt to remove it, the coil broke.The proximal section of the coil was inside the microcatheter and the distal segment was inside the aneurysm.The physician used a gooseneck snare device "to catch the coil inside the microcatheter" and cut the microcatheter to remove the coil and then remove the microcatheter from the patient's body.The physician continue the procedure with another coil and microcatheter.There was no reported clinical consequences to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 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: 5879349
• Report Number: 3008881809-2016-00122
• Device Sequence Number: 13737317
• Product Code: HCG
• UDI-Device Identifier: 04546540711540
• UDI-Public: (01)04546540711540(17)190131(10)18829185
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: M0036121450
• Device Lot Number: 18829185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2016
• Supplement Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR