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

Model Number 995081

Device Problems Unintended Ejection (1234); Leak/Splash (1354)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the x-force balloon leaked when it was tested.

Event Description

It was reported that the x-force balloon leaked when it was tested.

Manufacturer Narrative

The reported event was confirmed but the cause is unknown.The evaluation report of the returned sample, submitted by future matrix interventional, stated that when the catheter was attached to an in-house endoflator to investigate inflation, there was a leak mid barrel of the balloon.When the catheter leak location was visually inspected under 20x magnification, a circumferential hole, 5mm in length, was found 9cm from tip of catheter.A potential root cause of the reported event could be poor balloon design in terms of inadequate wall thickness and strength due to which balloon ruptured at or below the rated burst pressure (rbp), resulting in leak, user inconvenience and replacement of device.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 patient 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 patient 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 3 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.Storage store in a cool, dry and dark place.Do not store near radiation or ultraviolet light sources as these may damage product materials." 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.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: BARD X-FORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9126161
• MDR Text Key: 188850061
• Report Number: 1018233-2019-06009
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715
• Combination Product (y/n): N
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/09/2020

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 Expiration Date: 09/20/2021
• Device Model Number: 995081
• Device Catalogue Number: 995081
• Device Lot Number: BMCXFM41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1