MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problem Biofilm coating in Device (1062)

Patient Problems Pain (1994); Hematuria (2558)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

A (b)(6) year old male patient with an obstructive 7mm stone in the left ureter with pain, hydronephrosis and hematuria.The patient came in for more definitive procedure.The patient was brought to the cystoscopy suite and placed in the dorsal lithotomy position.The genitalia was then prepped and draped in a sterile fashion, and 2% xylocaine gel was instilled into the urethra.The patient was already on iv antibiotics.A 23fr sheath with a 30 degree lens cystoscope was inserted.The urethra appeared within normal limits.There was evidence of marked inflammation of the bladder neck and area of the left ureteral orifice.The stent, which biofilm was noted 1 week after placement, was grasped with rigid graspers and removed just outside the meatus.A.035 glidewire was then inserted nicely through the stent all the way up into the left kidney, and the stent was removed and stent to pathology.The scope was removed, and then a 9.5fr semirigid wolf ureteroscope was inserted and the stone was in the midureteral.It was basketed with 2.5fr basket, but the stone would not move through the lower ureter.Therefore, the physician inserted a 273 micron holmium laser fiber and the stone was broken into small pieces.The original fine basket broke and, therefore, the physician inserted a 2.8fr helical basket, which then trapped the larger stone fragments.They were removed nicely outside the ureter and outside the urethra.These were sent to pathology as well.A 23fr sheath with a 30 degree lens cystoscope was reinserted and a wire was reinserted all the way to the left kidney.Under fluoroscopy, a 6fr x 26 cm stent was inserted.The wire was removed outside the body and the stent was seen to curl nicely in the renal pelvis and in the bladder.Due to all of the bleeding and inflammation that was seen, a 20fr foley catheter was inserted and the bladder was emptied.The patient tolerated the procedure well.The patient was sent to postanesthesia unit without any complications.The patient will follow up in two days to remove the catheter.The patient will have cipro for seven days and will follow up in approximately twelve days to remove the stent in office.The patient tolerated the procedure well.The patient was sent to post anesthesia unit without any complications.The patient will follow up in two days to remove the catheter.The patient will have cipro for seven days and will follow up in approximately twelve days to remove the stent in office.Additional information has been requested, however it was not provided at the time of this report.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, drawing, instructions for use, manufacturing instructions and quality control and a visual inspection of the returned product was conducted during the investigation.The visual examination determined that only a portion of the stent was returned.It was also noted that the stent did not break during the procedure, but rather cut after the procedure in order for the customer to perform test on the biofilm as well.Visual inspection of the returned portion of the product confirms the presence of encrustation.This encrustation is likely comprised of calcium deposits and blood.No side ports on the returned portion of the product were visibly occluded.There is no evidence to suggest that the device was not made to specification.The ifu cautions that: ¿complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.¿ ¿individual variations of interactions between stents and urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.¿ the appropriate internal personal have been notified.We will continue to monitor for similar complaints.

Event Description

A (b)(6) year old male patient with an obstructive 7mm stone in the left ureter with pain, hydronephrosis and hematuria came into the facility for more definitive procedure.The patient was brought to the cystoscopy suite and placed in the dorsal lithotomy position.The genitalia was then prepped and draped in a sterile fashion, and 2% xylocaine gel was instilled into the urethra.The patient was already on iv antibiotics.A 23fr sheath with a 30 degrees lens cystoscope was inserted.The urethra appeared within normal limits.There was evidence of marked inflammation of the bladder neck and area of the left ureteral orifice.The stent, which biofilm was noted 1 week after placement, was grasped with rigid graspers and removed just outside the meatus.A.035 glidewire was then inserted nicely through the stent all the way up into the left kidney, and the stent was removed and stent to pathology.The scope was removed, and then another manufacturer's 9.5fr semirigid ureteroscope was inserted and the stone was in the midureter.It was basketed with 2.5fr basket, but the stone would not move through the lower ureter.Therefore, the physician inserted a 273 micron holmium laser fiber and the stone was broken into small pieces.The original fine basket broke and, therefore, the physician inserted a 2.8fr helical basket, which then trapped the larger stone fragments.They were removed nicely outside the ureter and outside the urethra.These were sent to pathology as well.A 23fr sheath with a 30 degrees lens cystoscope was reinserted and a wire was reinserted all the way to the left kidney.Under fluoroscopy, a 6fr x 26 cm stent was inserted.The wire was removed outside the body and the stent was seen to curl nicely in the renal pelvis and in the bladder.Due to all of the bleeding and inflammation that was seen, a 20fr foley catheter was inserted and the bladder was emptied.The patient tolerated the procedure well.The patient was sent to postanesthesia unit without any complications.The patient will follow up in two days to remove the catheter.The patient will have cipro for seven days and will follow up in approximately twelve days to remove the stent in office.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5142088
• MDR Text Key: 27986995
• Report Number: 1820334-2015-00639
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-626-RT1
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2015
• Event Location: Hospital
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 118