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

Catalog Number	998404
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon part of the balloon dilation catheter was damaged.The balloon did not inflate when used.Per follow up information received via ibc on 25jan2025, stated that the damage to the balloon could not be confirmed by visual inspection.The balloon had not burst.It seems to be leaking.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual: the sample was received within a ziploc back marked with a biohazard label and sterilized by eo sterilization.Customer complaint number was handwritten on the bag.The catheter was inside the ziplock bag with a syringe attached to the winged hub of the catheter via stopcock.No packaging or labeling materials were present with the ziplock bag.No liquid was present within the catheter or the attached syringe.Functional: the catheter had been used as the guard was missing and it did not appear that the balloon had been inflated.The sample was evaluated in the engineering lab.Visual inspection was completed of the device upon receipt, and in initial review, there was no initial visual damage or breakage found on the balloon, or the balloon tip.In addition, a visual inspection of the outer shaft, the balloon hub, wire hub and the y-connector showed no visible damage at the initial inspection.The tip, hubs, and y-connectors were then inspected under magnification and no damage was immediately identified on the catheter.After a visual inspection was completed, the syringe and stopcock were attempted to be removed from the winged hub of the catheter.The stopcock was tightly secured to the winged hub and was unable to be removed.The reviewer instead removed the syringe from the stopcock and attached an inflation device with an additional stopcock to complete the physical inspection.The catheter had a 0.038" guidewire placed through the guidewire lumen where resistance was noted at the first marker band location in the balloon.With slight pressure applied, the guidewire passed the marker band and again found resistance at the tip of the balloon.Greater pressure was applied and the guidewire passed through.Some residue was seen on the tip of the guidewire; however, this is believed to be the result of the cleaning materials during the disinfecting and sterilization of the sample.No mention of guidewire passage issues was noted on the complaint.Once the guidewire was placed, the catheter was attempted to be inflated.The balloon was able to be inflated at 12 atms and held pressure.No leaks were identified at the time.The balloon was inspected under magnification.It was noted that one of the port holes appeared to be compressed, however; it was able to transfer fluid into the balloon.Under magnification, no damage, tears, or leaks in the balloon were identified.The balloon was then pressurized to 16atms and held pressure for approximately 10 seconds, then lost pressure as the winged hub began to leak.The balloon was deflated, and the stopcock and inflation device were removed.Under magnification there was a crack identified in the winged hub and other stresses markings found on the hub.A review of the component dmr for the etched and non-etched hubs were completed.Hub lots 22080036 and 23080709 were revied and there were no non-conformances or abnormalities found in the manufacturing or inspection of the hubs.All manufacturing parameters were within specification and all inspections were found to result in conforming product.Also received 3 photo samples.First photo sample shows top view of inflation device and balloon dilation catheter.Second and third photo samples shows end of catheter with deflated balloon.No actions can be taken at this time since a root cause was not identified.Dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: 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 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.Correction: d, e, h.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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 or Problem Description
It was reported that balloon part of the balloon dilation catheter was damaged.The balloon did not inflate when used.Per follow up information received via ibc on 25-jan-2025, stated that the damage to the balloon could not be confirmed by visual inspection.The balloon had not burst.It seems to be leaking.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21354577
• Report Number: 1018233-2025-00778
• Device Sequence Number: 9078549
• Product Code: EZN
• UDI-Device Identifier: 10801741052641
• UDI-Public: (01)10801741052641(11)240612(17)260731(10)BMJPFM26
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 998404
• Device Lot Number: BMJPFM26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown