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

Lot Number BMDQFM19

Device Problems Break (1069); Entrapment of Device (1212); Retraction Problem (1536)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/29/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, (b)(6) male presented to ed with persistent symptoms of dysuria, chills, nausea and vomiting, and left-sided flank pain radiating to the suprapubic region.Pt was recently treated for a complicated uti status post esbl infection and obstructive uropathy with stone 1.5 cm.On (b)(6) 2019, pt had a left percutaneous nephrostolithotomy.The nephrostomy tubes as well as access wires into his bladder were identified.Next, a flexible cystoscope was then brought in the field and flexible cystoscopy was then performed.There are 2 wires identified in the bladder, one of which was engaged with a foreign body grasper and brought out of the urethral meatus and this was then used to attempt to pass the ureteric access sheath into the ureter in a retrograde fashion.This proved impossible.The sheath was removed.Obturator was advanced also with difficulty.So at this time, physician elected to not place the sheath any longer and maintain the wire through the penis on a clamp as a safety wire.The second wire in the bladder was used as a working wire and going back to the patient's flank working wire was not utilized to advance a balloon dilating catheter.A bard x-force was utilized 15 cm and 30-french size.The lower pole nephrostomy tube was left in place to drainage and balloon dilation of the tract was then done in usual fashion under fluoroscopy guidance and direct vision.During dilation, an hourglass deformity was noted at the level of the fascia and then subsequently the balloon spontaneously deflated having developed a leak and for that reason, the balloon dilating catheter was exchanged out and it was noted that at that point the distal 6cm of the balloon was no longer attached to the catheter.It became separated from it and was now trapped with contrast in it within the tract of the nephrostomy.At this time, interventional radiology was called and under a separate incision, the radiologist with assistance proceeded to endeavor to snare the balloon and retrieve it as thoroughly and completely as possible.After about 45 minutes of multiple attempts and multiple wire placements and utilization of the second nephrostomy tract for access, this proved impossible and was temporarily abandoned and terminated.After nephroscopy was performed and stone was removed the nephroscope was utilized to carefully examine for the presence of the fractured retained dilating balloon fragment in the renal pelvis, could not be found.However, because it contained contrast, it was possible to image with the imaging c-arm to see that it was still present in the nephrostomy tract, and so with the sheath held firmly with nephroscope in place, the sheath was then carefully maneuvered out of the nephroscopy tract until it was possible to visualize the fractured dilating fragment outside of the renal parenchyma within what appeared to be gerota's fascia or the retroperitoneum.Multiple attempts were made to engage the fractured balloon fragment.These were all done successfully; however, the balloon fragment would not actually migrate when it was pulled and utilized multiple devices despite the fact that it could be clearly visualized and engaged, it could not be brought out.During an exchange of instrumentation, the nephroscope was then reintroduced and under fluoroscopy it was possible to see that with reintroduction of the nephroscope, the distal retained.Fda safety report id # (b)(4).

• Brand Name: BARD X-FORCE
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): C.R. BARD, INC.; covington
• MDR Report Key: 9290741
• MDR Text Key: 165967597
• Report Number: MW5090926
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/05/2019

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
• Device Lot Number: BMDQFM19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2019
• 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: 48 YR
• Patient Weight: 96