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

Catalog Number	M0036181450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that when the physician attempted to insert the subject coil, it detached at the hand part of the microcatheter (non stryker).The procedure was completed with other product without any issues.There were no clinical consequences to the patient due to the reported event.
Event or Problem Description
It was reported that when the physician attempted to insert the subject coil, it detached at the hand part of the microcathter (non stryker).The procedure was completed with other product without any issues.There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device found the main coil was kinked and was detached from the delivery wire.Functional testing could not be performed due to the condition of the returned device.As per the additional information, the flush was intermittent which is against the device direction for use (dfu) for this product.The dfu states: 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 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.Lack of continuous flush contributed to the reported and analysed defects.It is likely that the coil got stuck inside the microcatheter (due to no flush) and it then kinked and detached from the delivery wire while it was being retracted with force.Based on the available information and investigation results, an assignable cause of user error will be assigned to this investigation.The issue investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.

• Brand Name: TARGET XXL 360 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: 8765118
• Report Number: 3008881809-2019-00196
• Device Sequence Number: 1541720
• Product Code: HCG
• UDI-Device Identifier: 07613327128383
• UDI-Public: 07613327128383
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 08/21/2019

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: 01/05/2022
• Device Catalogue Number: M0036181450
• Device Lot Number: 2118704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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: MICROCATHETER ( LEONIS MOVA); MICROCATHETER ( LEONIS MOVA)