FDA.reportPublic FDA data

MAUDE MDR 8545748

MDR report key
8545748
Report number
1220948-2019-00046
Event key
0
Event type
3
Date of event
2019-03-26
Date received
2019-04-24
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
1HYDRO LEMAITRE VALVULOTOMEVALVULOTOMELEMAITRE VASCULAR, INC.MGZ1009-00ELVH1064VY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-240

Event Narratives#

N

Patient 1

WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND IT IS CONFIRMED THAT ONE OF THE BLADES IS CAUGHT ON THE RETAINER SLOT. WE DID PULL ON THE GREEN HANDLE TO CLOSE THE CENTERING HOOPS/BLADES AND OBSERVED THAT THE BLADE WAS PROTRUDING OUT OF THE RETAINER SLOT AND DIDN'T SEAT PROPERLY. THE CENTERING HOOP OF THIS SAME BLADE WAS ALSO FOUND BENT. DEVICE WAS CHECKED FOR PROPER BLADE ALIGNMENT BY THE SURGEON BEFORE THE PROCEDURE AS INSTRUCTED IN THE IFU AND HE FOUND TO BE OPERATIONAL. THE BLADES ALSO FUNCTIONED PROPERLY DURING THE FIRST PASS. OUR LOT HISTORY RECORD REVIEW FOR THIS LOT NUMBER DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER IN THE MANUFACTURING OR THE PACKAGING PROCESSES. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. PLEASE NOTE THAT WE DO CONDUCT 100% INSPECTION OF THE BLADE ASSEMBLY DURING THE MANUFACTURING PROCESS. OUR QUALITY CONTROL ALSO SAMPLES THESE DEVICES BEFORE FINAL PACKAGING TO ENSURE PROPER BLADE ADJUSTMENT. IT IS LIKELY THE BLADE OR THE CENTERING HOOP WAS DAMAGED DURING THE PROCEDURE INFLUENCED BY PATIENT'S ANATOMY/CONDITION SINCE THE DEVICE WAS FOUND TO BE OPERATIONAL DURING PREUSE CHECK. THERE WAS NO IMPACT ON PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER HYDRO VALVULOTOME.

D

Patient 1

DURING VALVULOTOMY OF SAPHENOUS VEIN, SURGEON COULD NOT CLOSE ONE OF THE BLADES INTO ITS HOUSING. SURGEON WAS ABLE TO PROPERLY CUT THE VALVES OF THE VEIN DURING THE FIRST PASS. THE ISSUE WAS DETECTED PRIOR TO THE SECOND PASS WHEN THE DEVICE WAS OUTSIDE OF THE PATIENT'S VESSEL . SURGEON ALSO CHECKED THE BLADES FOR PROPER BLADE ALIGNMENT DURING PRE-USE CHECK AND FOUND IT TO ACCEPTABLE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THE OPERATION COMPLETED SUCCESSFULLY BY USING ANOTHER HYDRO VALVULOTOME THAT THEY HAD IN STOCK.