FDA.reportPublic FDA data

MAUDE MDR 9769631

MDR report key
9769631
Report number
2029214-2020-00174
Event key
0
Event type
3
Date of event
2019-11-12
Date received
2020-02-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MGR. KATCHA TAYLOR
Address
9775 TOLEDO WAY IRVINE CA 92618 US
Phone
949-949-9496
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MARKSMANCATHETER, CONTINUOUS FLUSHMICRO THERAPEUTICS, INC. DBA EV3KRAFA-55150-1030217757006Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-280

Event Narratives#

N

Patient 1

AS THE DEVICE WAS RECEIVED IN A CONDITION WAS CONTRADICTORY TO THE COMPLAINT DESCRIPTION. THE MARKSMAN CATHETER FOUND SEPARATED. THIS CONDITION WAS NOT REPORTED AT TIME OF THE EVENT. AS RECEIVED, THE MEDTRONIC FLOW DIVERSION WAS RETURNED WITHIN THE MARKSMAN CATHETER. THE FLOW DIVERSION PUSHWIRE WAS FOUND PROTRUDING FROM WITHIN THE MARKSMAN HUB. NO DAMAGES WERE FOUND WITH THE MARKSMAN HUB. THE MARKSMAN CATHETER BODY WAS FOUND ACCORDIONED AND SEPARATED FROM THE PROXIMAL END OF THE HUB. IN ADDITION, THE MARKSMAN CATHETER BODY WAS FOUND ACCORDIONED FROM THE DISTAL TIP. DURING EVALUATION, THE MARKSMAN CATHETER WAS DISSECTED (CUT) TO REMOVE THE STUCK FLOW DIVERSION EMBOLIZATION DEVICE. BASED ON THE RETURNED DEVICE DEVICE ANALYSIS AND REPORTED INFORMATION, IT APPEARS THAT THERE WAS HIGH FORCE USED. IT IS LIKELY THIS DAMAGE OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE FLOW DIVERSION THROUGH THE MARKSMAN CATHETER AGAINST RESISTANCE SUBSEQUENTLY CAUSING THE CATHETER TO BECOME SEPARATED. BASED ON THE INVESTIGATION CONDUCTED RESISTANCE CAN OCCUR DURING TRACKING, DEPLOYMENT AND RE-SHEATHING OF THE DEVICE IN DISTAL AND TORTUOUS ANATOMIES. IN ADDITION, RESISTANCE CAN OCCUR DUE TO PATIENT VESSEL TORTUOSITY, FAILURE TO MAINTAIN A CONTINUOUS FLUSH, OR EMBOLIZATION DEVICE IS PULLED BACK/TORQUED DURING DELIVERY. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY AND A CONTINUOUS FLUSH WAS MAINTAINED. THEREFORE, THE CAUSE COULD NOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

MEDTRONIC RECEIVED INFORMATION THAT RESISTANCE WAS ENCOUNTERED WHILE PUSHING THE MEDTRONIC FLOW DIVERSION THROUGH THE DISTAL SECTION OF THE MARKSMAN MICROCATHETER, AND THE FLOW DIVERSION COULD NOT BE RELEASED NORMALLY. THE BOTH CATHETER AND FLOW DIVERSION REMOVED FROM THE PATIENT. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT WITH FLOW DIVERSION FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE RIGHT OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 7.17MM AND A NECK DIAMETER OF 5.75MM. THE DISTAL LANDING ZONE WAS 4.16MM AND THE PROXIMAL LANDING ZONE WAS 4.24MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE MARKSMAN CATHETER WAS SEPARATED FROM THE PROXIMAL END OF THE HUB.