FDA.reportPublic FDA data

MAUDE MDR 6347659

MDR report key
6347659
Report number
1220948-2017-00015
Event key
0
Event type
3
Date received
2017-02-21
Adverse event
0
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 01803 US
Phone
781-781-7812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0HYDRO LEMAITRE VALVULOTOMEVALVULOTOMELEMAITRE VASCULAR, INC.MGZ1009-00ELVH1107VY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-210

Event Narratives#

N

Patient 1

WE HAVE RECEIVED AND EVALUATED THE COMPLAINT DEVICE. WE WERE ABLE TO CONFIRM THE REPORTED INCIDENT. TAILS OF THE CENTERING HOOP WERE PROTRUDING OUT OF THE SHEATH IN BOTH DEVICES PREVENTING CLOSURE OF THE CENTERING HOOP. 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. HOWEVER, WE DID INITIATE A CORRECTIVE ACTION TO INVESTIGATE AND RESOLVE COMPLAINTS RELATED TO SIMILAR ISSUES. WE HAVE IMPLEMENTED A DESIGN CHANGE TO OUR DEVICE THAT INCLUDES A HEAT SHRINK COVERING OF THE BLADES. WE BELIEVE THIS CHANGE, ALONG WITH SOME OTHER PROCESS IMPROVEMENTS, WILL ELIMINATE THE ISSUE THAT OUR CUSTOMER EXPERIENCED. WE ARE AWARE OF THIS ISSUE AND HAVE AN ONGOING RECALL THAT INCLUDES THIS LOT NUMBER. WE HAVE INFORMED THIS HOSPITAL REGARDING THIS ISSUE ON 02/03/2017. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

D

Patient 1

DURING VALVULOTOMY, BLADES OF THE VALVULOTOME DID NOT CLOSE INTO THE SHEATH. HE OPENED A SECOND DEVICE AND EXPERIENCED SIMILAR ISSUE. SURGEON PERFORMED REVERSE VALVULOTOMY TO COMPLETE THE PROCEDURE.