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

Catalog Number	998806
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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: sections 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 procedure, the balloon dilation catheter balloon was opened and found to be damaged, with the pressure pump leaking.They replaced with a new balloon.
Additional Manufacturer Narrative
Initial reporter complete facility name: (b)(6).The reported event was unconfirmed.Received (2) photo samples.The photo sample was returned and could not be evaluated for the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), used balloon dilation catheter with an eagle inflation device.Visual inspection of the sample noted that the returned device was visually inspected in the engineering lab, and no damage, deformities, or abnormalities were found on the shaft, hubs, or balloon.A guidewire passed through the device without resistance.Functional testing showed no leaks at 8 atm or 30 atm, including at the balloon, hub, inflation port, or stopcock.Based on the complaint details, any issue appears related to the inflation device, which was not returned for evaluation.The complaint could not be confirmed.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.Corrections made to tab(s) d and 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 during the procedure, the balloon dilation catheter balloon was opened and found to be damaged, with the pressure pump leaking.They replaced with a new balloon.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: 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, GA 30014 ; 7707846100
• MDR Report Key: 23708808
• Report Number: 1018233-2025-10730
• Device Sequence Number: 18821586
• Product Code: EZN
• UDI-Device Identifier: 10801741052771
• UDI-Public: (01)10801741052771(11)240501(17)260731(10)BMJRFM16
• 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): 03/24/2026

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: 998806
• Device Lot Number: BMJRFM16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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