FDA.reportPublic FDA data

MAUDE MDR 6333463

MDR report key
6333463
Report number
1220948-2017-00009
Event key
0
Event type
3
Date of event
2017-01-18
Date received
2017-02-15
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 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.MGZ1009-00ELVH1113VY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-1501. R

Event Narratives#

N

Patient 1

WE HAVE RECEIVED AND EVALUATED THE COMPLAINT DEVICE. WE WERE ABLE TO CONFIRM THE REPORTED INCIDENT. ONE TAIL OF THE CENTERING HOOP WAS PROTRUDING OUT OF THE SHEATH PREVENTING CLOSURE OF THE DEVICE. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES THAT IN EITHER THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. HOWEVER, WE DID INITIATE A CORRECTIVE ACTION ON 7/17/2016 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 FEBRUARY 10, 2017. SALES OFFICE AT (B)(4) HAVE CONFIRMED THAT THIS HOSPITAL HAD NO MORE INVENTORY OF ELVH1113V.

D

Patient 1

DURING VALVULOTOMY, DOCTOR FELT STRONG RESISTANCE AS HE WAS CLOSING THE BLADES OF THE VALVULOTOME. IN ORDER TO TAKE THE CATHETER OUT OF THE VEIN, HE OPENED THE PROXIMAL SITE OF THE ANASTOMOSIS AND EXPOSED ABOUT 15 CM FROM THE CATHETER TIP. HE THEN CUT THE CATHETER AND TOOK OUT THE SEPARATED CATHETER FROM THE VESSEL.