SURGITEK PTFE COATED GUIDEWIRE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-10 for SURGITEK PTFE COATED GUIDEWIRE * manufactured by Zircon- Cabot.

Event Text Entries

[57719] Procedure: right ureteroscopy and right percutaneous nephrostomy. This 57-year-old white male came to er w/right flank pain radiating to lower quadrant of abdomen and it was associated with nausea. This is first renal colic, he never had history of kidney stones. His mother had history of kidney stones. A 23 fr cystoscope was introduced into bladder under dilation and bladder and urethra appeared normal. There was no reflux or urine coming out of right ureteral orifice. 8 fr cone-tipped ureteral catheter was inserted into right ureteral orifice and about 8 cc of dye was injected and an x-ray was done, that showed stone in right mid ureter and then a guide wire was inserted into right ureter over guide wire. It was attempted to dilate intramural ureter. Intramural ureter was dilated with cook urethral dilators. It could be dilated up to 9 fr and 10 fr urethral dilator could not be advanced up. Then leaving guide wire in, cystoscope was removed. Cystoscope was reintroduced into bladder and a 5 fr ureteral catheter was attempted to pass into right ureter and it was not going up into ureter. It was curling up in intramural ureter. Then leaving guide wire in, cystoscope was removed. Alongside previously placed guide wire 11. 5 fr ureteroscope was inserted into lumen of right ureter to see lumen of ureter clearly. Through that a 5 fr open ended ureteral catheter was attempted to pass. Ureteral catheter was bending at beak of ureteroscope and so another guide wire was passed into right ureter and over that, ureteral catheter was attempted to pass. Ureteral catheter was not going up so it was decided to inject some xylocaine into ureter through open ended ureteral catheter after taking out guide wire. Ureteral catheter was curling up in the intramural ureter so just at beak of the ureteroscope about 20 cc of xylocaine jelly was injected into the right ureter. Jelly was coming out around ureteroscope out of ureter. Then several attempts were made to pass open ended ureteral catheter up and other one was left in and then guide wire was back loaded through cystoscope and then a 29 cm 6 fr ureteral stent was inserted into kidney over guide wire. After stent went into kidney, it was attempted to take out guide wire. Guide wire was defective and it broke. Threads were coming out so guide wire was not coming out of ureteral stent. It was attempted to pull guide wire in, it was stuck and it was not coming out so it was attempted to pull lower end of stent out of cystoscope so that a new guide wire could be passed but guide wire could not be removed so without taking out stent. Guide wire along with stent had to be retrieved with alligator forceps and it was attempted to pass another guide wire and it was going into ureteral wall. It could be passed into kidney. It was attempted to see lumen of ureter because of bleeding and ragged edges of ureteral mucosa floating into ureter, lumen could not be seen clearly so it was decided to do a percutaneous nephrostomy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number104935
MDR Report Key104935
Date Received1997-07-10
Date of Report1997-07-10
Date of Event1997-07-02
Date Facility Aware1997-07-02
Report Date1997-07-10
Date Reported to FDA1997-07-10
Date Reported to Mfgr1997-07-10
Date Added to Maude1997-07-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSURGITEK PTFE COATED GUIDEWIRE
Generic NameGUIDEWIRE
Product CodeEYA
Date Received1997-07-10
Model Number*
Catalog Number*
Lot Number279366J
ID NumberPRODUCT # 2738
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key103186
ManufacturerZIRCON- CABOT
Manufacturer Address609 BEACHWOOD RD. WILLOW GROVE PA 19090 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 1997-07-10

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