FDA.reportPublic FDA data

MAUDE MDR 8646769

MDR report key
8646769
Report number
3009211636-2019-00131
Event key
0
Event type
3
Date of event
2019-04-04
Date received
2019-05-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA HERNANDEZ
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MAHURKARCATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTEDCOVIDIEN MFG SOLUTIONS S.A.NIE8888101002HP8888101002HP1803700080Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-2801. D

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

ACCORDING TO THE REPORTER, PATIENT WAS ON AN EMERGENT CASE AND CAME IN WITH CHEST PAIN AND NEEDED STENT PLACEMENT, DURING THE PLACEMENT OF TRIPLE LUMEN DIALYSIS CATHETER, THE PATIENT WAS PLACED IN THE SUPINE POSITION IN MILD TRENDELENBERG. UNDER ULTRASOUND GUIDANCE, THE LEFT FEMORAL VEIN WAS IDENTIFIED. THE PATIENT WAS THEN DRAPED AND PREPPED IN THE USUAL STERILE MANNER. AFTER ADEQUATE LOCAL ANESTHESIA WAS OBTAINED, THE VEIN WAS CANNULATED. USING SELDINGER TECHNIQUE, A GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE. IMAGING OF THE GUIDEWIRE CONFIRM THAT GUIDEWIRE OUTSIDE VEIN. GUIDEWIRE WAS REMOVED AND WAS FOUND TO BE KINKED AND ALL BECAME UNRAVELED WITH FIXED RESISTANCE AT ONE POINT. AVAILABLE DILATOR WAS APPLIED, AND THE GUIDEWIRE RETRACTED BUT WAS UNSUCCESSFUL. SMALLER DILATOR WAS USED AND WITH RETRACTION, SUCCESSFULLY REMOVED (COMPLETE). PRESSURE WAS APPLIED TO AREA UNTIL HEMOSTASIS. AT THE SECOND ATTEMPT, USING SELDINGER TECHNIQUE, A GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE. AFTER THE SUBCUTANEOUS SKIN WAS APPROPRIATELY DILATED, A FR (FRENCH) 20 CM TRIPLE LUMEN DIALYSIS CATHETER WAS PLACED. BOTH DIALYSIS PORTS AND THIRD ACCESS PORT WERE EASILY ASPIRATED AND FLUSHED WITH NORMAL SALINE AND THE CATHETER SUTURED TO THE SKIN USING 2-0 SILK. THE CATHETER WAS IN PLACE FOR FIVE (5) DAYS BEFORE THE PATIENT EXPIRED. IT WAS LATER REPORTED THAT THE PATIENT WAS DECEASED, AND CARDIOGENIC SHOCK WAS DETERMINED TO BE THE CAUSE OF DEATH. IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.