FDA.reportPublic FDA data

MAUDE MDR 8091953

MDR report key
8091953
Report number
1220948-2018-00099
Event key
0
Event type
3
Date of event
2018-10-22
Date received
2018-11-20
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.DWQ7201387Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-200

Event Narratives#

N

Patient 1

WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE MDU HOUSING AND POWER CORD WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THE DRIVE SHAFT ROTATED SLIGHTLY WHEN THE RUN BUTTON WAS PRESSED BUT DID NOT ROTATE TO THEIR FULL SPEED. WE COULD NOT DISASSEMBLE THE CORE TUBE AT THIS TIME AS ONE OF THE END BELL PINS REQUIRES MACHINING IN ORDER TO BE REMOVED. THE DRIVE SHAFT DID NOT ROTATE WHEN WE TRIED TO ROTATE THE DRIVE SHAFT USING THE FORCE WITH OUR HAND, WHICH INDICATES THAT THE BALL BEARINGS MIGHT HAVE SEIZED IN THIS DEVICE, WHICH COULD HAVE LED TO THIS ISSUE. WE HAVE ALREADY IMPLEMENTED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO RESOLVE THIS ISSUE BY REPLACING THE BALL BEARINGS WITH SLIP BEARINGS. THIS DEVICE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THESE CHANGES. THERE WAS NO INJURY TO THE PATIENT SINCE THE ISSUE WAS DETECTED DURING PRE-USE CHECK. THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.

D

Patient 1

DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE WHEN IT WAS CONNECTED TO THE CONTROL UNIT.