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

Catalog Number	998706
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 on may 15, 2024, when the third people's hospital of fujian province performed a ureteral dilation operation, a ureteral balloon dilation catheter was required during the operation.After opening the outer packaging of the product, when the syringe was filled with water, it was found that the connector leaked and could not be used.Subsequently, the surgery was continued with new products.
Event or Problem Description
It was reported that on may 15, 2024, when the (b)(6) performed a ureteral dilation operation, a ureteral balloon dilation catheter was required during the operation.After opening the outer packaging of the product, when the syringe was filled with water, it was found that the connector leaked and could not be used.Subsequently, the surgery was continued with new products.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted the sample was received in a closed ziploc bag identified with a biohazard label and sterilized by eo label.Inside of the bag there was a balloon catheter with the refold tool and there was no guard neither stopcock.The balloon hub of the catheter reads "7 mm x 6 cm" and "30 atm"; the wire hub reads "0.038 (0.97 mm) wire".Visual inspection was performed to the balloon catheter, and no damages or abnormalities were observed in the balloon, however it was noticed a minor crack in one of the parting lines of the hub, the crack starts from the top of the hub and ends up tot he wing in the balloon hub.Functional evaluation noted functional testing was performed introducing a 0.038" guidewire through the wire hub, the guidewire passed freely through the catheter.Then the catheter was filled with distilled water using an inflation device, but it was not possible to inflate the balloon due to a leak in the balloon hub connector.Dhrs for the subassembly and molded hub were reviewed and there are no ncrs related to the reported complaint.Also received one video sample that shows in live time of water leaking out from the connector when the syringe is in use.Based on photo and physical sample received the reported event is confirmed.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be compressed assembled components.However, there was insufficient information to confirm this potential root cause.Based on this information the risk is low.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 description 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 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 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.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.

• 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 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: 19458204
• Report Number: 1018233-2024-03230
• Device Sequence Number: 6652960
• Product Code: EZN
• UDI-Device Identifier: 10801741052740
• UDI-Public: (01)10801741052740(11)220806(17)250401(10)BMGUFM43
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 04/01/2025
• Device Catalogue Number: 998706
• Device Lot Number: BMGUFM43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2022
• 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