MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035478300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during avf (arteriovenous fistula) sigmoid sinus procedure, the subject device (coil) was stuck inside the coil mass.The subject device was withdrawn carefully but it was prematurely detached inside the microcatheter.Since the subject device was tangled with the coil mass, the subject device was retrieved and safely removed from the patient by using snare device.The procedure was finished without additional coil.The patient¿s current condition is fine.No clinical consequences to the patient were reported.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.It was noted during analysis that the main coil was stuck in the catheter with the snare device.Upon removal the coil could be seen to be extremely damaged and was not attached to the delivery wire.Upon microscopic analysis, the main coil can be seen to be kinked and was tangled.The main coil had detached from the delivery wire at the main coil junction and this was seen to have occurred but physical force, resume ably when the snare was trying to be retracted.Functional testing was not performed due to the damage noted to the coil.Additional information from the customer indicated that the device was stated to have been in good condition prior to the procedure and was prepared as per the device directions for use (dfu).Based on device analysis and the information available, it is probable the device was damaged due to some procedural/anatomical factors encountered during procedure, causing the reported medical intervention.As such, an assignable cause of operational problem due to component failure was assigned to this event.
Event or Problem Description
It was reported that during avf (arteriovenous fistula) sigmoid sinus procedure, the subject device (coil) was stuck inside the coil mass.The subject device was withdrawn carefully but it was prematurely detached inside the microcatheter.Since the subject device was tangled with the coil mass, the subject device was retrieved and safely removed from the patient by using snare device.The procedure was finished without additional coil.The patient¿s current condition is fine.No clinical consequences to the patient were reported.

• Brand Name: TARGET 360 SOFT 8MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7858444
• Report Number: 3008881809-2018-00392
• Device Sequence Number: 18889191
• Product Code: HCG
• UDI-Device Identifier: 04546540676603
• UDI-Public: 04546540676603
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• 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): 10/25/2018

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: 11/30/2018
• Device Catalogue Number: M0035478300
• Device Lot Number: 18721880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 09/08/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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: XT-17 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention