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

Model Number	998806
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician inspected the balloon dilation catheter prior to operation for a patient with urethral stenosis and no problem was noted.However, the pressurization pump leaked water during dilatation for the patient.The event included extra operation and drug therapy.Per follow-up information received from ibc on (b)(6) 2022, the extra operation and drug therapy they had was the replacement of new device.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all of 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 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 of 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 physician inspected the balloon dilation catheter prior to operation for a patient with urethral stenosis and no problem was noted.However, the pressurization pump leaked water during dilatation for the patient.The event included extra operation and drug therapy.Per follow-up information received from ibc on 05aug2022, the extra operation and drug therapy they had was the replacement of new device.Per follow-up information received from ibc on 12aug2022, stated that there was no extra operation and drug therapy to replace the new device.
Event or Problem Description
It was reported that the physician inspected the balloon dilation catheter prior to operation for a patient with urethral stenosis and no problem was noted.However, the pressurization pump leaked water during dilatation for the patient.The event included extra operation and drug therapy.Per follow-up information received from ibc on 05aug2022, the extra operation and drug therapy they had been the replacement of a new device.Per follow-up information received from ibc on 12aug2022, stated that there was no extra operation and drug therapy to replace the new device.
Additional Manufacturer Narrative
Per investigator evaluation, bd has determined that this mdr event is not reportable.H11:section a through f - the information provided by bd represents all of 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 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: 15224680
• Report Number: 1018233-2022-06365
• Device Sequence Number: 12154159
• 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,Followup
• Report Date (Section B): 01/20/2023

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: 07/14/2024
• Device Model Number: 998806
• Device Catalogue Number: 998806
• Device Lot Number: BMGQFM12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/12/2022; 01/20/2023
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 08/25/2022; 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Age: 45 YR
• Patient Sex: Male