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

Catalog Number	997606
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after opening the balloon dilation catheter package, the lower part of the balloon head was found to be obviously damaged.Replaced with a new balloon for the surgery.
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 after opening the balloon dilation catheter package, the lower part of the balloon head was found to be obviously damaged.Replaced with a new balloon for the surgery.
Additional Manufacturer Narrative
The initial reporter's facility name: (b)(6).The reported event was confirmed cause unknown.The returned sample was received in a ziplock bag labeled as biohazard and eo sterilized, with the catheter found loose inside the packaging.Residual liquid was observed within the balloon, indicating prior use.Visual inspection identified clear damage to the outer shaft of the catheter, which appeared to have burst during use, while no additional damage, irregularities, or deformities were observed on the balloon, shaft (outside of the burst area), or hubs.No functional testing could be performed due to the condition of the device.Dimensional inspection of the outer shaft around the burst area showed that inner diameter, outer diameter, and wall thickness measurements were within specification.Review of the device history record (dhr) for the applicable lot found no abnormalities or nonconformances.Evaluation of the catheter identified a burst in the outer shaft located just below the balloon catheter.No additional abnormalities or damage were noted outside of the burst area.Dimensional analysis was performed on the outer shaft on both sides of the burst.Inner diameter measurements were within specification, as the applicable gage pin passed on either side of the burst and continued to pass when measured closer to the burst location.Based on the available evaluation, the burst of the outer shaft was observed and documented and found to be at (0.0765 in) on either side of the burst.Further analysis may be required to determine root cause.Based on the complaint description, balloon deformation or damage could not be confirmed.However, a burst of the outer shaft was observed, and additional root cause analysis is planned to further evaluate this issue.No final root cause could be determined, however identified potential root cause should be considered as contributing factors.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, 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: 23524035
• Report Number: 1018233-2025-10160
• Device Sequence Number: 9021556
• Product Code: EZN
• UDI-Device Identifier: 00801741052101
• UDI-Public: (01)00801741052101(11)240903(17)270325(10)BMJVFM18
• 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): 03/27/2026

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 Catalogue Number: 997606
• Device Lot Number: BMJVFM18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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