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

Catalog Number	998806
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
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 before the ureteral stricture dilation surgery, when the ureteral stricture balloon dilation catheter was opened and ready for use, it was obvious that the pressure pump gauge was broken.The pressure value did not change after slowly increasing the pressure.Per follow up information received via ibc on 18apr2025, stated that the balloon had been used on patients, but at that time, due to a leak in the pump, there was no significant impact on patients, health care professionals, or others.However, there had been several cases of this situation, and the head nurse and surgeon in the operating room had asked us to give an explanation of the product quality.Lot#bmjnfm09 and lot#unk.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned video sample noted one opened (without original packaging), used balloon dilation catheter.Visual inspection of the sample noted that the balloon dilation catheter connected to the pressure pump gauge and leakage was observed, unable to verify where the breakage was located.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.Correction: d,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 before the ureteral stricture dilation surgery, when the ureteral stricture balloon dilation catheter was opened and ready for use, it was obvious that the pressure pump gauge was broken.The pressure value did not change after slowly increasing the pressure.Per follow up information received via ibc on 18apr2025, stated that the balloon had been used on patients, but at that time, due to a leak in the pump, there was no significant impact on patients, health care professionals, or others.However, there had been several cases of this situation, and the head nurse and surgeon in the operating room had asked us to give an explanation of the product quality.Lot#bmjnfm09 and lot#unk.

• Brand Name: BARD® X-FORCE® 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21926076
• Report Number: 1018233-2025-03088
• Device Sequence Number: 12940324
• Product Code: EZN
• UDI-Device Identifier: 10801741052771
• UDI-Public: (01)10801741052771(11)220201(17)260430(10)BMJNFM09
• 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): 12/17/2025

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: 04/30/2026
• Device Catalogue Number: 998806
• Device Lot Number: BMJNFM09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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