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

Catalog Number	996081
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
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.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 during the erics procedure the balloon dilation catheter failed to inflate properly because contrast liquid leakage from the manometer during fluid insufflation.(batch#bmgwat01), (batch#bmgyfm44).Per follow up information received via ibc on 09 sep 2024, customer conformed, event during use and need to change percutaneous dilatation device.
Event or Problem Description
It was reported that during the erics procedure the balloon dilation catheter failed to inflate properly because contrast liquid leakage from the manometer during fluid insufflation.(batch#bmgwat01), (batch#bmgyfm44).Per follow up information received via ibc on 09sep2024, customer conformed, event during use and need to change percutaneous dilatation device.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that during the erics procedure the balloon dilation catheter failed to inflate properly because contrast liquid leakage from the manometer during fluid insufflation.(batch#bmgwat01, batch#bmgyfm44).Per follow up information received via ibc on 09sep2024, customer conformed, event during use and need to change percutaneous dilatation device.
Additional Manufacturer Narrative
The reported event was confirmed use to the over-pressurization of the device which would cause the o-ring to deform leading to device leaking.No actions are required at this time since root cause was not identified.A 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® 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." 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® NEPHROSTOMY 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20278868
• Report Number: 1018233-2024-05955
• Device Sequence Number: 7742402
• Product Code: LJE
• UDI-Device Identifier: 10801741127653
• UDI-Public: (01)10801741127653(11)230105(17)250430(10)BMGYFM44
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063632
• 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,Followup
• Report Date (Section B): 01/22/2025

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: 04/30/2025
• Device Catalogue Number: 996081
• Device Lot Number: BMGYFM44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024; 01/23/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/21/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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