FDA.reportPublic FDA data

MAUDE MDR 8417510

MDR report key
8417510
Report number
1820334-2019-00654
Event key
0
Event type
3
Date received
2019-03-13
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. LARRY POOL
Address
750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone
812-812-8123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPEN-END URETERAL CATHETERGBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERYCOOK INCGBL0200137275576R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-130

Event Narratives#

N

Patient 1

CONCOMITANT MEDICAL PRODUCTS: 6FR PEDIATRIC SCOPE, WIRE GUIDE, 4FR STENT. OCCUPATION: OTHER HEALTHCARE PROFESSIONAL. PMA/510K # ? EXEMPT PRE-AMENDMENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

D

Patient 1

IT IS REPORTED DURING A CYSTOSCOPY WITH RETROGRADES USING A 6FR PEDIATRIC CYSTOSCOPE AND A COOK OPEN-END URETERAL CATHETER, SEVERAL PIECES OF THE URETERAL CATHETER BROKE OFF IN THE BLADDER. THE SURGEON WAS ABLE TO RETRIEVE ALL OF THE PIECES DURING THE SAME PROCEDURE USING GRASPERS. AFTER REMOVING THE PIECES, THE SURGEON PLACED A WIRE GUIDE, THEN PLACED A 4FR STENT WITH FLUORO AND INJECTED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. ADDITIONAL PATIENT SPECIFIC DETAILS WERE REQUESTED, HOWEVER THE COMPLAINT FACILITY STATED THAT THEY COULD NOT RELEASE PATIENT SPECIFIC INFORMATION.