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

Catalog Number	998606
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	07/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Full facility name: (b)(6).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 after pressurizing to 25atm, the balloon dilation catheter lost pressure, and it was found that the balloon had burst and leaked.The balloon was replaced and reused.The user was exposed to hazardous materials, blood or body fluids.
Event or Problem Description
It was reported that after pressurizing to 25atm, the balloon dilation catheter lost pressure, and it was found that the balloon had burst and leaked.The balloon was replaced and reused.The user was exposed to hazardous materials, blood or body fluids.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one photo sample noted one opened (without original packaging), used balloon dilation catheter.Visual inspection of the first photo sample shows a close up view of a tubular balloon dilation catheter with a rupture at the end.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, 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: 22564499
• Report Number: 1018233-2025-06024
• Device Sequence Number: 3904072
• Product Code: EZN
• 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): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 998606
• Device Lot Number: BMJUFM16
• Date Returned to Manufacturer: 07/19/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 05/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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