FDA.reportPublic FDA data

MAUDE MDR 8532737

MDR report key
8532737
Report number
1220948-2019-00044
Event key
0
Event type
3
Date of event
2019-03-20
Date received
2019-04-19
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
MR. PRAGYA THIKEY
Address
63 SECOND AVE BURLINGTON MA 01803 US
Phone
781-781-7812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRIVEX SYSTEM RESECTOR HANDPIECEVARICOSE VEIN ALBATION SYSTEMLEMAITRE VASCULAR, INC.DWQ7210387FYB02407Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-190

Event Narratives#

N

Patient 1

WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. HOWEVER, WE WERE UNABLE TO CONFIRM THE REPORTED INCIDENT AS WE WERE UNABLE TO REPLICATE THE REPORTED INCIDENT DURING OUR EVALUATION. THE HOUSING AND POWER CORD WERE VISUALLY INSPECTED AND WERE FOUND ACCEPTABLE. THE INDICATOR ON THE CONTROL UNIT PROPERLY FLASHED SOLID GREEN WHEN THE HANDPIECE WAS CONNECTED TO THE CONTROL UNIT. THE DEVICE PROPERLY FUNCTIONED ON ALL SETTINGS AND SPEED. UPON DISASSEMBLY, WATER WAS OBSERVED INSIDE THE CORE TUBE. THE ROOT CAUSE WAS DETERMINED TO BE A SEAL FAILURE THAT LED TO WATER INGRESS INTO THE HANDPIECE, WHICH INTERMITTENTLY AFFECTED THE MOTOR FUNCTIONALITY. WE CURRENTLY HAVE A CAPA OPEN TO ADDRESS THIS ISSUE. THE CORRECTIVE ACTION INCLUDES REPAIRS BY REPLACING THE CURRENT SEAL HOUSING WITH A NEW SEAL HOUSING ASSEMBLY, O-RINGS AND SWITCH PCB AND MOTOR IF THERE IS ANY EVIDENCE OF WATER INSIDE THE CORE TUBE. WE BELIEVE THESE CHANGES WILL BETTER PREVENT WATER AND STEAM FROM ENTERING INTO THE INNER COMPONENTS OF THE HANDPIECE. PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE THAT THEY HAD IN STOCK.

D

Patient 1

DURING TIPP ( TRANSILLUMINATED POWERED PHLEBECTOMY) PROCEDURE, THE RESECTOR FAILED TO ROTATE. SO, THE PROCEDURE WAS COMPLETELY USING A DIFFERENT HANDPIECE. THERE WAS NO INJURY OR ANY ADVERSE EVENT TO THE PATIENT AS THE RESULT OF THIS INCIDENT.