FDA.reportPublic FDA data

MAUDE MDR 3590800

MDR report key
3590800
Report number
3590800
Event key
0
Event type
3
Date of event
2013-11-25
Date received
2013-11-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ERASE CAUTIFOLEY CATHETERMEDLINE INDUSTRIES, INC.NWR**QUKP Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-11-260

Event Narratives#

D

Patient 1

FOLEY WILL NOT DEFLATE.====================== MANUFACTURER RESPONSE FOR FOLEY CATHETER, MEDLINE (PER SITE REPORTER).======================1. IT SOUNDS TO HIM AS IF THE INFLATION VALVE IS NOT ENGAGING, SO HE ASKED THAT THEY REALLY PUSH THE SYRINGE (OR PULL ANOTHER SYRINGE) INTO THE VALVE TO ENSURE THAT ITS ENGAGING PROPERLY. ONCE THEY DO THIS AND GET THE VALVE TO ENGAGE, THEN ALLOW THE BALLOON TO PASSIVELY DEFLATE.2. IF THAT DOESN'T WORK, CUT THE CATHETER JUST ABOVE THE INFLATION VALVE, LIKE RIGHT WHERE THE SHRINK WRAP IS AROUND THE VALVE. SEE IF IT DRAINS, AND IF IT DOESN'T, ATTACH A SYRINGE TO THE OPENING AND PULL BACK. 3. IF THAT DOESN'T WORK, CUT THE INFLATION LUMEN RIGHT BY THE Y-JUNCTION. YOU'LL SEE TWO LUMENS, THE SMALLER ONE IS THE INFLATION LUMEN. USE A 16 OR 18 GAUGE NEEDLE IN THE SMALL LUMEN AND A SYRINGE AT THE END TO SUCK THE WATER OUT OF THE BALLOON. THIS CAN BE DONE AT THE BEDSIDE.4. IF ALL OF THE ABOVE DO NOT WORK, ITS LIKELY NECESSARY TO CALL THE UROLOGIST.5. USE A GUIDE WIRE TO GO UP INTO THE INFLATION LUMEN AND POP THE BALLOON. THIS CAN BE DONE AT THE BEDSIDE.