MAUDE MDR 1546778

MDR report key
1546778
Report number
1825146-2009-00037
Event key
0
Event type
3
Date of event
2009-08-13
Date received
2009-11-25
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
CHRIS KILANDER
Address
1100 WEST MORGAN SPENCER IN 47460 US
Phone
812-812-8128
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SKINNY NEEDLE PERCUTANEOUS ENTRY NEEDLEFHR NEEDLE, GASTRO-UROLOGYCOOK UROLOGICAL, INC.FHRNA090010UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-11-2501. R

Event Narratives#

D

Patient 1

DURING A PERCUTANEOUS NEPHROSTOMY WITH FLUOROSCOPIC GUIDANCE, A 0.038 / 150CM NITINOL GUIDEWIRE WITH HYDROPHILIC COATING (BARD DEVICE) WAS INSERTED THROUGH A 20 GAUGE SKINNY NEEDLE WITH CHIBA TIP. AS THE GUIDEWIRE WAS PULLED BACK TO RE-DIRECT TO THE CORRECT LOCATION WITHIN THE KIDNEY, RESISTANCE WAS FELT. THE GUIDEWIRE WAS REMOVED WITH SOME RESISTANCE AND A NEW ONE WAS INSERTED THROUGH THE SAME NEEDLE. RESISTANCE WAS MET WHEN PULLING THE WIRE BACK INTO THE NEEDLE. A THIRD GUIDEWIRE WAS USED, AND THE RESISTANCE WAS FELT AGAIN. ULTIMATELY, A NEPHROSTOMY TUBE WAS PLACED IN THE RENAL PELVIS. THREE WEEKS LATER, A PERCUTANEOUS LITHOTRIPSY WAS DONE AND FOUR DAYS AFTER THAT A NEPHROSTOGRAM WAS PERFORMED. ON THE SCOUT FILM, A FOREIGN BODY WAS SEEN IN THE DISTAL URETER. UNDER GENERAL ANESTHESIA, THE FOREIGN BODY WAS REMOVED. THE UROLOGIST IDENTIFIED THE FOREIGN BODY AS THE HYDROPHILIC COATING THAT IS OVER THE GUIDEWIRE. THE PATHOLOGIST IDENTIFIED THE SPECIMEN AS "FOUR THREADLIKE FRAGMENT 1 CM TO 4 CM IN LENGTH, AND A TAN-WHITE FRAGMENT - 0.5CM." REMOVAL OF FOREIGN BODY.

N

Patient 1

A PROPER EVAL CANNOT BE PERFORMED DUE TO NOT BEING PROVIDED THE DEVICE, LOT # OR PART # FOR THE INCIDENT. UPON CONTACTING RISK MGMT TO OBTAIN ADDITIONAL INFO, THE CONTACT HAD STATED ANY ADDITIONAL INFO REQUESTED WOULD HAVE TO BE PUT INTO WRITING NOTING THREE REQUESTS HAVE BEEN SENT WITHOUT RESPONSE. IN REVIEWING THE SPECIFICATIONS FOR A COOK 20GA SKINNY NEEDLE, THE INSIDE DIAMETER WOULD NOT ALLOW AN .038" WIREGUIDE TO BE PLACED INSIDE THE NEEDLE. ADDITIONALLY, WHEN USING A POLYMER COATED WIREGUIDE THROUGH A NEEDLE, CARE SHOULD BE TAKEN TO ASSURE THE WIREGUIDE IS NOT ANGLED CAUSING THE NEEDLE BEVEL TO SCRAPE OR CUT THE POLYMER COATING OFF OF THE WIREGUIDE. UPON RECEIPT OF ADDITIONAL INFO, IT WILL BE FORWARDED.