FDA.reportPublic FDA data

MAUDE MDR 8254720

MDR report key
8254720
Report number
1220948-2019-00005
Event key
0
Event type
3
Date of event
2018-12-17
Date received
2019-01-16
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.MGZ1009-00ELVH1477VAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-160

Event Narratives#

N

Patient 1

WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION SINCE THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. OUR LOT HISTORY RECORDS REVIEW FOR THIS LOT NUMBER DID NOT REVEAL ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESSES THAT COULD BE RELATED TO THIS INCIDENT. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS RELATED TO A SIMILAR ISSUE FOR DEVICES FROM THIS LOT NUMBER. PLEASE NOTE THAT WE DO CONDUCT 100% INSPECTION OF THE BLADE ASSEMBLY DURING THE MANUFACTURING PROCESS. OUR QUALITY GROUP ALSO SAMPLES THESE DEVICE BEFORE FINAL PACKAGING TO ENSURE PROPER BLADE ADJUSTMENT. IT IS POSSIBLE THAT THE BLADE WAS DAMAGED DURING PACKAGING OR DURING SHIPPING THE DEVICE TO THE HOSPITAL . OUR IFU CLEARLY INFORMS USERS TO INSPECT THE BLADES FOR DAMAGE AND ALIGNMENT PRIOR TO USE. IN THIS CASE, THE USER PROPERLY FOLLOWED THE RISK MITIGATION MEASURES (IFU) AND PROPERLY IDENTIFIED THE ISSUE. DEVICE WAS NOT USED IN THE PATIENT. ANOTHER VALVULOTOME WAS USED FOR THE SURGERY.

D

Patient 1

ONE OF THE FOUR CUTTING BLADES OF THE VALVULOTOME DID NOT CLOSE PROPERLY INTO ITS HOUSING. THE MALFUNCTION WAS DETECTED BY THE SURGEON DURING PRE-USE CHECK. SO, THE DEFECTIVE DEVICE WAS REPLACED WITH A NEW VALVULOTOME.