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

Catalog Number	998806
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery for ureteral stricture using a balloon dilation catheter, the doctor found that the pump could not pressurize the balloon.After replacing it with a set of u30, the surgery could be normal.As per information mentioned in the internal bd comments on 30oct2023, stated that the product did not show any defects from the outside.Hx: the patient had surgery for ureteral stricture.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product meets specifications.Visual evaluation noted the samples was evaluated in the bio testing lab, first performing a visual inspection of the device and no visible anomalies were identified.Inside of the balloon there are residues of a clear liquid, but there was not irregularities in the balloon.Upon completion of the visual inspection.Functional evaluation noted functional testing was performed introducing a 0.038" guidewire through the wirehub; the guidewire was introduced without resistance through all the catheter inner lumen hub.Then using the balloon hub the catheter was filled with distilled water using an inflation device.The balloon was inflated and then it was pressurized up to 30atm without shown leaks or irregularities.Afterwards, the balloon was deflated applying vacuum in the inflation device and it was deflated without problems.Based on the results of the sample evaluation, this complaint is unconfirmed since the balloon was inflated and deflated without complications and no irregularities were observed.A dhr reviews are not required as the reported event.The labelling review are not required as the reported event is unconfirmed.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that during the surgery for ureteral stricture using a balloon dilation catheter, the doctor found that the pump could not pressurize the balloon.After replacing it with a set of u30, the surgery could be normal.As per information mentioned in the internal bd comments on 30oct2023, stated that the product did not show any defects from the outside.

• 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 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: 18139752
• Report Number: 1018233-2023-08140
• Device Sequence Number: 6560050
• Product Code: EZN
• UDI-Device Identifier: 10801741052771
• UDI-Public: (01)10801741052771
• 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): 01/23/2024

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: 01/04/2025
• Device Catalogue Number: 998806
• Device Lot Number: BMGWFM05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2022
• 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