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

Catalog Number	998004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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: 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 water leakage occurred from the tip of the foley catheter balloon during the third balloon expansion as the balloon was ruptured.
Event or Problem Description
It was reported that during the procedure water leakage occurred from the tip of the foley catheter balloon during the third balloon expansion as the balloon was ruptured.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.The sample was received within a ziplock bag marked with a biohazard label and sterilized by eo sterilization.Customer complaint number (b)(4) is labeled on the bag.The catheter was returned loose inside the ziplock bag attached to an inflation device.A cut box of the packaging was included within the ziplock bag.The catheter had been used as the guard was missing and it appeared that the balloon had been inflated.The sample was returned with debris from the cleaning agent covering the sample.The sample was evaluated in the engineering lab.Visual inspection was completed of the device upon receipt, and in initial review, there was no 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 found during visual inspection.After a visual inspection was completed, a functional and physical inspection was performed.The catheter had a 0.038 in guide wire placed through the guidewire lumen.Once the guidewire was placed, the catheter was attempted to be inflated.The balloon was able to be inflated, however, once inflated, a small leak was immediately identified in the distal cone of the balloon.The balloon was inspected under magnification and what appeared to be a small hole was identified.The balloon was then dissected to remove the fibers and evaluate the base balloon.After fibers were removed, a small hole was able to be identified as the source of the leak.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: d, e, f, h.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.

• 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: 21873634
• Report Number: 1018233-2025-02839
• Device Sequence Number: 8741873
• Product Code: EZN
• UDI-Device Identifier: 10801741052795
• UDI-Public: (01)10801741052795(11)240731(17)260831(10)BMJVFM01
• 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): 03/19/2026

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: 08/31/2026
• Device Catalogue Number: 998004
• Device Lot Number: BMJVFM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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