MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER; NEPHROSTOMY CATHETER

Catalog Number 996101

Device Problems Break (1069); Entrapment of Device (1212); Leak/Splash (1354); Difficult to Remove (1528)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that an x-force balloon dilating catheter spontaneously deflated.It developed a leak during dilation of the nephrostomy tract in a male patient who underwent percutaneous nephrostolithotomy for obstructive uropathy and a 1.5 cm stone.The balloon catheter was exchanged, and it was noted that at the 6 cm distal point, the balloon was no longer attached to the catheter.The balloon was separated from the catheter and trapped, with contrast in the balloon, within the nephrostomy tract.A second incision was made.An interventional radiologist assisted with multiple attempts to snare and retrieve the balloon with multiple wire placements through the second incision for about 45 minutes, unsuccessfully.After the nephroscopy was performed and the stone was removed, a nephroscope was performed to look for the fractured, retained balloon fragment in the renal pelvis and it could not be found.It was imaged with c-arm and seen in the nephrostomy tract.The sheath was then maneuvered out of the nephrostomy tract until it was possible to visualize the fractured fragment outside of the renal parenchyma within what appeared to be gerota¿s fascia or the retroperitoneum.Multiple attempts were again made to engage the fragment; however, it would not migrate when it was pulled, despite the use of multiple devices and that it was clearly visualized and engaged.During an exchange of instrumentation, the nephroscope was re-introduced under fluoroscopy and it was possible to see that the distal portion was still retained.Additional information was received the patient had a left vats extraction of the left pleural cavity to remove the foreign body.The procedure was successful and the patient tolerated it well.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction: d1, d2, d4, g5.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that an x-force balloon dilating catheter spontaneously deflated.It developed a leak during dilation of the nephrostomy tract in a male patient who underwent percutaneous nephrostolithotomy for obstructive uropathy and a 1.5 cm stone.The balloon catheter was exchanged, and it was noted that at the 6 cm distal point, the balloon was no longer attached to the catheter.The balloon was separated from the catheter and trapped, with contrast in the balloon, within the nephrostomy tract.A second incision was made.An interventional radiologist assisted with multiple attempts to snare and retrieve the balloon with multiple wire placements through the second incision for about 45 minutes, unsuccessfully.After the nephroscopy was performed and the stone was removed, a nephroscope was performed to look for the fractured, retained balloon fragment in the renal pelvis and it could not be found.It was imaged with c-arm and seen in the nephrostomy tract.The sheath was then maneuvered out of the nephrostomy tract until it was possible to visualize the fractured fragment outside of the renal parenchyma within what appeared to be gerota¿s fascia or the retroperitoneum.Multiple attempts were again made to engage the fragment; however, it would not migrate when it was pulled, despite the use of multiple devices and that it was clearly visualized and engaged.During an exchange of instrumentation, the nephroscope was re-introduced under fluoroscopy and it was possible to see that the distal portion was still retained.Additional information was received the patient had a left vats extraction of the left pleural cavity to remove the foreign body.The procedure was successful and the patient tolerated it well.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.The evaluation report of the returned sample, submitted by futurematrix interventional, states that only a balloon sample was received.There was blood inside the sample.The inner shaft that was still attached to the balloon appeared to be jagged / broken off.The distal marker was still attached on the inner shaft.The balloon seemed to be crumpled.In the proximal end, there were loose fibers and pebax noted.A potential root cause of the reported event could be "inadequate material selection".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "instructions for use caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Description the x-force® nephrostomy balloon dilation catheter is a dual lumen catheter with a 24 (8mm) or 30fr (10mm) balloon mounted on the distal tip.It has a radiopaque tip and a radiopaque marker beneath the balloon.The lumen labeled with rated burst pressure (xx atm) is for balloon inflation.The other lumen allows the catheter to track over a 0.038¿ (.97mm) diameter guidewire and can be used for monitoring of pressure or the infusion of medication and/or contrast medium.Each balloon inflates to a stated diameter and length at a specific pressure ¿ typically at 10 atm.The balloon dilation catheter comes packaged with a refolding tool and a working sheath.It is available with or without an inflation device.It comes sterile and is for single use only.Indications for use the x-force® nephrostomy balloon dilation catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.Contraindications do not use the x-force® nephrostomy balloon dilation catheter in the presence of conditions which create unacceptable risk during the dilation of the nephrostomy tract.Warnings: ¿ if resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to the product.Applying excessive force to the catheter can result in tip breakage or balloon separation.¿ do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media.¿ this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Precautions: ¿ only a physician who has an understanding of the clinical applications, technical principles and associated risks associated with balloon dilation of the nephrostomy tract should use this device.¿ after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable laws and regulations.Potential complications the complications that may arise from a balloon dilation procedure include tissue trauma and perforation.Inspection prior to use the x-force® nephrostomy balloon dilation catheter is a sterile, single use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident.Preparation of the catheter all x-force® nephrostomy balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated.1.Remove the protective sheath from the balloon.2.Attach the inflation device to the connector on the balloon lumen.3.Open the stopcock, and draw back on the inflation device to remove the air from the balloon catheter 4.Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the balloon catheter.5.Repeat steps 3-4 until all air is removed from the balloon lumen.Catheter insertion 1.Prior to insertion, place the working sheath over the balloon and position it proximal to the balloon.Note: dilation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment or direct vision.2.Introduce the catheter carefully over a 0.038¿ (.97mm) guidewire and place it in the area that needs to be dilated.Use the radiopaque marker to aid in proper positioning.Caution: do not advance or withdraw the catheter or guidewire against any significant resistance.The cause of the resistance must be determined fluoroscopically and remedial action taken.Inflating the balloon catheter 1.Fill the inflation device (eagle¿ inflation device) with sterile, liquid media.2.Attach the inflation device to the balloon lumen.3.Open the stopcock and inflate the balloon.4.Once dilation has been attained, advance the sheath over the balloon.Warning: do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media.Note: the use of an inflation device with a pressure gauge is highly recommended to make sure adequate pressure is applied and the maximum limits of the balloon are not exceeded.Note: slight reduction in balloon pressure may be required if resistance is encountered when advancing the sheath over the balloon.Caution: do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded.Please refer to the device label for the recommended rbp.Deflating the balloon catheter deflate the balloon using an inflation device.Since deflation times vary based on balloon sizes and lengths, check fluoroscopically to confirm deflation before attempting to withdraw.1.Attach the inflation device (eagle¿ inflation device) and remove the solution from the balloon by pulling back on the inflation device.2.Remove the inflation device from the balloon catheter.This will allow ambient pressure to enter, relaxing the balloon.3.Gently withdraw the catheter.Use of a gentle counterclockwise twisting motion is recommended when removing the catheter.Warning: if resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to product.Applying excessive force to the catheter can result in tip breakage or balloon separation.Using the refolding tool the balloon catheter is supplied with a refolding tool.This aids in preparing the balloon for another insertion during the procedure.To use: 1.Manually compress the balloon.2.Position the refolding tool at one end.3.Twist the refolding tool counter clockwise and push down on the balloon until it goes the entire length of the balloon.4.Once the balloon is folded, remove the refolding tool and proceed with the procedure." h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that an x-force balloon dilating catheter spontaneously deflated.It developed a leak during dilation of the nephrostomy tract in a male patient who underwent percutaneous nephrostolithotomy for obstructive uropathy and a 1.5 cm stone.The balloon catheter was exchanged, and it was noted that at the 6 cm distal point, the balloon was no longer attached to the catheter.The balloon was separated from the catheter and trapped, with contrast in the balloon, within the nephrostomy tract.A second incision was made.An interventional radiologist assisted with multiple attempts to snare and retrieve the balloon with multiple wire placements through the second incision for about 45 minutes, unsuccessfully.After the nephroscopy was performed and the stone was removed, a nephroscope was performed to look for the fractured, retained balloon fragment in the renal pelvis and it could not be found.It was imaged with c-arm and seen in the nephrostomy tract.The sheath was then maneuvered out of the nephrostomy tract until it was possible to visualize the fractured fragment outside of the renal parenchyma within what appeared to be gerota¿s fascia or the retroperitoneum.Multiple attempts were again made to engage the fragment; however, it would not migrate when it was pulled, despite the use of multiple devices and that it was clearly visualized and engaged.During an exchange of instrumentation, the nephroscope was re-introduced under fluoroscopy and it was possible to see that the distal portion was still retained.Additional information was received the patient had a left vats extraction of the left pleural cavity to remove the foreign body.The procedure was successful and the patient tolerated it well.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: NEPHROSTOMY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9511864
• MDR Text Key: 172600990
• Report Number: 1018233-2019-08184
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 996101
• Device Lot Number: BMDQFM19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/23/2020; 03/16/2020
• Supplement Dates FDA Received: 01/30/2020; 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 96