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

Model Number	998606
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgical nurse found that the balloon of the balloon dilation catheter leaked water prior to use following unpacking.
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.
Event or Problem Description
It was reported that the surgical nurse found that the balloon of the balloon dilation catheter leaked water prior to use following unpacking.
Additional Manufacturer Narrative
The reported event was confirmed and cause was unknown.Photo samples were submitted.Evaluation of the first photo sample noted only the packaging with the product identifiers present.The second photo noted the eagle inflation device, however, could not be evaluated for the reported failure.Visual evaluation noted, no damages were observed in the balloon, however it was identified a crack in the balloon hub connector.Functional evaluation noted a 0.038" guidewire was introduced through the wire hub and it was noticed that the inner tube is collapsed in the body of the balloon, not allowing the full passage of the guidewire.Then the catheter was inflated with distilled water using an inflation device, the balloon was able to be inflated nevertheless it was not possible to pressurize it to operational pressure due to the leak in the balloon hub.The balloon hub is complete only with a small crack close to the wings and there is no evidence that it has been deformed by a crush, therefore is likely that the connector has been over torqued.Manufacturing process was reviewed, and it was confirmed that only plastic connectors are used to connect balloon hub for leak test and folding.Although an exact root cause could not be determined a potential root cause could be leaks.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.Inflating the balloon catheter: warning: do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded.Please refer to the device label for the recommended maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.¿ h11: 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 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: 16993113
• Report Number: 1018233-2023-03732
• Device Sequence Number: 3479876
• Product Code: EZN
• UDI-Device Identifier: 10801741052719
• UDI-Public: (01)10801741052719
• 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): 09/20/2023

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: 11/24/2023
• Device Model Number: 998606
• Device Catalogue Number: 998606
• Device Lot Number: BMFVFM24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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