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

Catalog Number 996081

Device Problems Leak/Splash (1354); Pressure Problem (3012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the pressure did not rise the second time during dilation.

Manufacturer Narrative

The reported event was confirmed.However, the cause is unknown.The sample was received coiled inside a sterilization pouch.Visual inspection noted the catheter sample appeared to have a dried, white powdery substance on the balloon, most likely because of the decontamination process.The catheter hubs were marked legibly with 8mm x 15cm and 0.038 (0.97mm wire).The y-connector hub was marked bard.The refold tool was present.The sample appeared to be in good condition.The catheter was visually inspected under 20x magnification and no deformities were noted.A guidewire was able to be passed with no issues.A new inflation device was used to inflate the catheter' balloon.Pressure was increased slowly as it is unknown if a previous inflation caused a burst resulting in a pinhole.Upon the attempt, the balloon did no inflate completely and one pinhole leak was observed approximately 2in from the distal tip.The balloon was deflated and inflated twice more to ensure that there were no other pinholes present.Only the one pinhole was observed.The balloon portion was cut away from the catheter and the inner polyimide was removed.The balloon portion was visually inspected under 45x magnification to better view the pinhole.The pinhole appeared to form outward from the balloon.For further investigation the balloon portion was dissected longitudinally to examine the pinhole from the inside.Under the 45x magnification, this revealed a longitudinal split of the pinhole directed outward.No scraping or deformities were observed around the pinhole.The complaint states 'it was reported that the pressure did not rise the second time during dilation.' it cannot be confirmed if pressure did rise or if it was exceeded during a first dilation which, if exceeded, can cause a burst in the balloon.It also can be confirmed if an inflation device with a pressure gage was used to monitor burst pressure.The root cause could not be determined.It could not be confirmed if pressure did rise or was exceeded during a first dilation which, if exceeded, can cause a burst in the balloon.It also cannot be confirmed if an inflation device with a pressure gage was used to monitor dilation pressure.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿the x-force® balloon dilation catheter is a dual lumen catheter with a balloon mounted on the distal tip.It has a radiopaque tip and two radiopaque markers beneath the balloon that define the working length.The lumen labeled with the 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 10 atm.The x-force® balloon dilation catheter comes packaged with a refolding tool and is available with or without an inflation device.It comes sterile and is for single patient use only.Indications for use the x-force® balloon dilation catheter is recommended for use in the dilation of the urinary tract.Contraindications do not use the x-force® balloon dilation catheter in the presence of conditions, which create unacceptable risk during the dilation of the urinary tract.Warnings ¿ 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 maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.¿ 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 caution: federal law (u.S.A.) restricts this device to sale by or on the order of a physician.Only a physician who has an understanding of the clinical applications, technical principles and associated risks of balloon dilation within the urinary tract should use this device.After use, the x-force® balloon dilation catheter and/or accessories may be considered a potential biohazard.Handle and dispose of in accordance with medical practice and applicable laws and regulations.Inspection prior to use the x-force® 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® 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.Introduce the catheter carefully over a 0.038¿ (.97mm) guidewire and place it in the area that needs to be dilated.Use the radiopaque markers to aid in proper positioning.Note: dilation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment or direct vision.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 diluted contrast medium.2.Attach the inflation device to the balloon lumen.3.Inflate the balloon note: do not use air or any gaseous substances as a balloon inflation medium 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 rated burst pressure of the balloon is not exceeded.Caution: if loss of pressure in the balloon occurs or the balloon ruptures, immediately stop the procedure, deflate the balloon and remove carefully.Do not attempt to re-inflate the balloon.If after inspection it is noted pieces of the balloon are missing, check for and endoscopically retrieve the fragments when possible.Warning: 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 maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.Deflating the balloon catheter deflate the balloon using an inflation device.Since deflation times vary based on balloon sizes and shaft lengths, check fluoroscopically to confirm deflation before attempting to withdraw.1.Attach the inflation device (eagle¿ inflation device) to the balloon catheter 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.Caution: if resistance is felt when removing either the catheter or the guidewire from the introducer 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.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 of the balloon.3.Twist the refolding tool counter clockwise and push down on the balloon until the refolding tool traverses the entire length of the balloon.4.Once the balloon is folded, remove the refolding tool and proceed with the procedure.Dispose of properly.Storage store the balloon dilation catheter in a cool, dry, dark place.Do not store near radiation or ultraviolet light sources as these may damage product materials.".

Event Description

It was reported that the pressure did not rise the second time during dilation.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: X-FORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8028459
• MDR Text Key: 125999064
• Report Number: 1018233-2018-05138
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

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 Catalogue Number: 996081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1