FDA.reportPublic FDA data

MAUDE MDR 6595203

MDR report key
6595203
Report number
1220948-2017-00035
Event key
0
Event type
3
Date of event
2017-04-20
Date received
2017-05-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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.MGZ1009-00ELVH1125VY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-2601. O; 2. R

Event Narratives#

N

Patient 1

WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WE HAVE CONFIRMED THE REPORTED INCIDENT. WE FOUND THAT THE CENTERING HOOPS DID NOT CLOSE ALL THE WAY INSIDE THE SHEATH WHEN THE GREEN HANDLE WAS PULLED. THE DEVICE WAS ABLE TO CLOSE WHEN HELD STRAIGHT BUT COULD NOT CLOSE COMPLETELY WHEN WE TRIED TO CLOSE THE HOOPS IN U-CONFIGURATION. WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. THE INVESTIGATION IS ONGOING. IT IS POSSIBLE THE FRICTION BETWEEN THE INSIDE WALL OF THE SHEATH AND THE WIRE CAUSED BY DRIED BLOOD INSIDE THE CATHETER HAS CONTRIBUTED TO THIS ISSUE. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR DEVICES FROM THIS LOT. SINCE THE CATHETER WAS REMOVED IN THE OPEN POSITION, THE BLADE CUT THE DISTAL END OF THE PATIENT'S SAPHENOUS VEIN . THE VEIN WAS STILL USED SUCCESSFULLY FOR BYPASS AND WAS ABLE TO BE ANASTOMOSED TO THE ARTERY.

D

Patient 1

DURING SECOND PASSAGE OF IN-SITU BYPASS, PHYSICIAN COULD NOT CLOSE THE BLADES INTO THE RETAINER WHILE PULLING THE CATHETER AT THE DISTAL END OF THE VEIN. ALSO, THEY COULD NOT COMPLETELY OPEN THE CATHETER. SO, THE PHYSICIAN PULLED THE CATHETER RELUCTANTLY AND CUT THE DISTAL END OF THE VEIN SINCE THE CENTERING HOOPS WERE REMOVED IN THE OPEN POSITION.