FDA.reportPublic FDA data

MAUDE MDR 6207935

MDR report key
6207935
Report number
1220948-2015-00026
Event key
0
Event type
3
Date of event
2016-11-14
Date received
2016-12-27
Adverse event
3
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 MA 01803 US
Phone
781-781-7812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROCOL BIOLOGIC VASCULAR GRAFTVASCULAR GRAFTLEMAITRE VASCULAR, INC.LXAHJL016-40-NY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-2701. R

Event Narratives#

N

Patient 1

WE HAVE RECEIVED AND INVESTIGATED THE COMPLAINT DEVICE FOR REPORTED INCIDENT. WE HAVE CONFIRMED THE DEFECT. WE FOUND THAT THE DEVICE WAS OOZING WITH SOME PERMEABILITY FROM ONE POINT NEARER TO ONE END FROM THE GRAFT. THIS IS A BIOPROSTHETIC DEVICE AND VARIATION ALONG THE GRAFT IS NORMAL. OUR IFU DOES STATE THAT A "SMALL AMOUNT OF OOZING IS ACCEPTABLE". ALL GRAFTS ARE SUBJECTED FOR LEAK TESTING PRIOR TO ACCEPTANCE INTO INVENTORY.

D

Patient 1

WHEN THE SURGICAL TECH WAS FLUSHING THE GRAFT, HE NOTICED THE GRAFT WAS LEAKING FROM THE MIDPOINT OF THE GRAFT. SO, HE CLAMPED THE DISTAL END AND LIGHTLY FLUSHED THE GRAFT, WHICH THEN SHOWED DIFFUSE WEEPING FROM MULTIPLE AREAS. NO OBVIOUS DEFECT WAS NOTED. THE GRAFT WAS THEN DISCARDED AND THEN ANOTHER GRAFT WAS USED. THE GRAFT WAS NOT USED IN THE PATIENT.