FDA.reportPublic FDA data

MAUDE MDR 6840486

MDR report key
6840486
Report number
1625425-2017-00121
Event key
0
Event type
3
Date of event
2017-08-03
Date received
2017-09-01
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
MS. GAIL SMITH
Address
1445 FLAT CREEK ROAD ATHENS TX 75751 US
Phone
214-214-2144
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1JAWZ EMB FORCEPSENDOMYOCARDIAL BIOPSY FORCEPSARGON MEDICAL DEVICES INC.DWZ190081G38301R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-010

Event Narratives#

N

Patient 1

A REVIEW OF THE DEVICE HISTORY RECORDS AND INSPECTION RECORDS WAS CONDUCTED AND NO SIMILAR CONCERNS WERE FOUND. NO SAMPLES OR PHOTOS WERE RETURNED, SO THE ISSUE COULD NOT BE CONFIRMED. SINCE THE SAMPLE IS NOT AVAILABLE FOR RETURN AND THERE WERE NO CONCERNS NOTED IN THE MANUFACTURING DOCUMENTATION, NO FURTHER EVALUATION CAN BE CONDUCTED AT THIS TIME.

D

Patient 1

THE INSULATION RIGHT BEHIND THE TIP CAME FREE WHEN THE USER PULLED BACK ON THE HANDLE. OF COURSE, THIS HAPPEN WHILE IN THE HEART. THE USER THINKS THE SPRING WAS CAUGHT ON THE TRICUSPID VALVE. IT TOOK ABOUT FIVE MINUTES OF MANIPULATING AND THE USER WAS FINALLY ABLE TO FREE IT WITHOUT RIPPING THE VALVE.