FDA.reportPublic FDA data

MAUDE MDR 7492544

MDR report key
7492544
Report number
1220948-2018-00027
Event key
0
Event type
3
Date of event
2018-04-10
Date received
2018-05-07
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.MGZ1009-00ELVH1317VY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-070

Event Narratives#

N

Patient 1

WE HAVE RECEIVED THE DEVICE FOR EVALUATION. WE HAVE CONFIRMED THE REPORTED INCIDENT. WE FOUND THAT ONE OF THE BLADE DID NOT CLOSE PROPERLY INTO ITS RETAINER WHEN THE CENTERING HOOPS WERE CLOSED. WE OBSERVED THAT THE CENTERING HOOP THAT CONNECTS TO THIS BLADE WAS DAMAGED WHICH LED TO THIS ISSUE. WE DID NOT OBSERVE ANY DAMAGE ON EITHER SIDE OF THE RETAINER. 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. THEREFORE, WE BELIEVE THAT IT WAS AN ISOLATED INCIDENT. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT. IT IS POSSIBLE THAT THE CENTERING HOOP WAS DAMAGED DURING PACKAGING OR DURING SHIPPING THE DEVICE TO THE HOSPITAL. THE ISSUE WAS DETECTED DURING PRE-USE CHECK. THE PROCEDURE WAS COMPLETED USING A DIFFERENT VALVULOTOME.

D

Patient 1

BEFORE THE PROCEDURE, THE SURGEON TESTED THE BLADES FUNCTIONALITY OF THE VALVULOTOME. THE SURGEON WAS UNABLE TO CLOSE ONE OF THE BLADES INTO ITS HOUSING.