MAUDE Adverse Event Report: C. R. BARD, INC. ENDUROLOGY BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER; CATHETER, NEPHROSTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/06/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a (b)(6) female pt admitted secondary to right sided obstructing proximal ureteric stone.Pt had nephrostomy tube placement and scheduled for percutaneous nephrostolithotomy on the right side.On (b)(6), pt underwent complex right-sided proximal nephrostolithotomy, holmium laser lithotripsy and basketing of stone fragments.During procedure, a mid pole access was obtained by interventional radiology and this was then utilized to advance 2 wires, a working wire and a safety wire down into the bladder, which was engaged with a flexible cystoscope and brought out o the urethra meatus and controlled with clamp.A ureteric access sheath was placed along the working wire into the distal and mid ureter all the way up to the obstructing stone and a foley catheter 14-french was placed in the bladder.Next, using the safety wire was clipped to the drape and the working wire was utilized to balloon dilate the nephrostomy tract, which was done with a 12 cm 30-french balloon dilating catheter, over this was advanced a 30-french nephrostomy access sheath.Once the sheath was placed in the renal pelvis, the balloon was removed and rigid nephroscope was then brought into the field.The pt tolerated the procedure well.The double-j stent was to remain in place for at least 4 to 5 wks.On (b)(6), a ct scan of abdomen and pelvis revealed that there appeared to be a small curvilinear radiopaque foreign body in the renal collecting system.This was faxed by radiology to the referring service at the time of dictation.On (b)(6), pt underwent ureteroscopy with basketing of the right renal pelvis foreign body.During procedure, there was a segment of what appeared to be distal part of sheath measuring about 7 x 7 mm.This was not collapsible or foldable and could not be removed through the sheath or the ureter.This was therefore left in place and the pt was sent to interventional radiology for percutaneous access and possible removal percutaneously.The foreign body was removed percutaneously and double-j stent was placed for drainage of kidney and resolution of nephrostomy tract.Grade ii cystocele retrograde pyelography showed no extravasation in the renal pelvis.The plan will be for foley catheter to remain in place 24-46 hours for drainage and then removal and ultimately removal of double-j stent in a week's time.There were no complications.Since the procedure was performed in august and the discovery of the foreign object was until december, there was no way of tracking the lot number of the nephrostomy balloon dilation catheter.The fragment of the device will be sent to the mfr.

• Brand Name: ENDUROLOGY BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 8069320
• MDR Text Key: 127245506
• Report Number: MW5081200
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 76