FDA.reportPublic FDA data

MAUDE MDR 5812179

MDR report key
5812179
Report number
1625425-2016-00036
Event key
0
Event type
3
Date of event
2016-06-22
Date received
2016-07-21
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
1APIG1260T] SKATER TRAY 6F PIGSKATER TRAY 6F PIGARGON MEDICAL DEVICESGBQAPIG1260TR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-2101. O

Event Narratives#

N

Patient 1

THE LOT NUMBER WAS NOT PROVIDED; THEREFORE,THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THERE WAS NO PATIENT INJURY. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE PRECISE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. THE IFU STATES TO VERIFY THE INTEGRITY OF THE CATHETER COMPONENTS BEFORE USE. IF A COMPONENT APPEARS DAMAGED, USE A REPLACEMENT CATHETER. THE SKATER? SAFETY CENTESIS CATHETER WITH PIGTAIL AND BLUNT RETRACTING STYLET IS INTENDED FOR ASPIRATION OF FLUID FROM THE BODY. IN THORACENTESIS, THE FLUID IS REMOVED FROM THE PLEURAL CAVITY. IT IS PROBABLE THAT THE DEVICE WAS PLACED TOO CLOSE TO A RIB AND THE BREATHING OF THE PATIENT CAUSED KINKING OF THE CATHETER WHICH REQUIRED HAND PUMPING OF THE FLUID BY THE PHYSICIAN.

D

Patient 1

THE PIGTAIL CATHETER WAS INSERTED INTO THORA DRAINAGE SPACE USING STANDARD TECHNIQUE. THE CATHETER WAS CLOSE TO A RIB. THE BREATHING OF THE PATIENT CAUSED KINKING IN THE CATHETER PREVENTING FLOW. THE FLUID HAD TO BE HAND PUMPED BY THE DOCTOR IN BETWEEN EACH RESPIRATION TO COMPLETE THE DRAINAGE.