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

Catalog Number	997606
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the once the balloon dilation catheter had been inflated, it cannot be completely deflated.The guide wire would slip into the ureter and out of the guide wire because the balloon catheter would not come out of the cystoscope working channel.Per additional information received on 08jan2025, it was reported that the once the balloon inflated, the balloon cannot be deflated completely, which leads to laceration in the ureter and loss of the guide wire due to the balloon catheter not exiting through the cystoscope working channel.Ureteroscopy was performed without a guide wire to position it, since after the laceration it was impossible to pass the guide through a cystoscope.
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 the once the balloon dilation catheter had been inflated, it cannot be completely deflated.The guide wire would slip into the ureter and out of the guide wire because the balloon catheter would not come out of the cystoscope working channel.Per additional information received on 08jan2025, it was reported that the once the balloon inflated, the balloon cannot be deflated completely, which leads to laceration in the ureter and loss of the guide wire due to the balloon catheter not exiting through the cystoscope working channel.Ureteroscopy was performed without a guide wire to position it, since after the laceration it was impossible to pass the guide through a cystoscope.Per follow up information received via ibc on 23jan2025, stated that there was no need for additional interventions due to the lacerations caused by the balloon.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: inspection prior to use: the x-force balloon dilation catheter is a sterile, single use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident.Preparation of the catheter: all x-force balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated.1.Remove the protective sheath from the balloon.2.Attach the inflation device to the connector on the balloon lumen.3.Open the stopcock and draw back on the inflation device to remove the air from the balloon catheter.4.Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the balloon catheter.5.Repeat steps 3-4 until all air is removed from the balloon lumen.Deflating the balloon catheter: deflate the balloon using an inflation device.Since deflation times vary based on balloon sizes and shaft lengths, check fluoroscopically to confirm deflation before attempting to withdraw.1.Attach the inflation device (eagle inflation device) to the balloon catheter and remove the solution from the balloon by pulling back on the inflation device.2.Remove the inflation device from the balloon catheter.This will allow ambient pressure to enter, relaxing the balloon.3.Gently withdraw the catheter.Use of a gentle counterclockwise twisting motion is recommended when removing the catheter.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.

• 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 30014 ; 7707846100
• MDR Report Key: 21102167
• Report Number: 1018233-2024-08648
• Device Sequence Number: 15619470
• Product Code: EZN
• UDI-Device Identifier: 00801741052101
• UDI-Public: (01)00801741052101(11)231003(17)260510(10)BMHWFM14
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 05/10/2026
• Device Catalogue Number: 997606
• Device Lot Number: BMHWFM14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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: Required Intervention
• Patient Sex: Unknown