FDA.reportPublic FDA data

MAUDE MDR 7940482

MDR report key
7940482
Report number
1220948-2018-00077
Event key
0
Event type
3
Date of event
2018-09-06
Date received
2018-10-05
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
2
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.MGZ1009-00ELVH1378VY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
02018-10-050

Event Narratives#

N

Patient 1

WE HAVE NOT YET RECEIVED THE DEVICE FOR EVALUATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER WE EVALUATE THE DEVICE. WE HAVE CONDUCTED A LOT HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. ALL OF THE 98 UNITS FROM THIS LOT RELEASED FOR SALE HAVE BEEN SOLD. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT. DEVICE WAS NOT USED IN THE PATIENT. ANOTHER VALVULOTOME WAS USED FOR THE SURGERY.

D

Patient 1

THE CUTTING BLADES OF THE VALVULOTOME DID NOT OPEN OR CLOSE PROPERLY. THE MALFUNCTION WAS DETECTED DURING PRE-USE CHECK. SO, THE DEFECTIVE DEVICE WAS REPLACED WITH A NEW VALVULOTOME.