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

Catalog Number	998806
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
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 the balloon dilatation pump leaked during use, making it impossible for the balloon to be inflated and expanded.Per follow up information received on 26jul2024, stated that the balloon was not broken.The pressurized pump leaked so that the balloon could not be expanded.
Additional Manufacturer Narrative
The reported event was unconfirmed as the product meets specifications.Visual evaluation noted one inflation device and inflator tray was returned to atrion inside a plastic bag.The device exhibits the cts mark indicating 100% functional verification at the time of manufacture and the gauge was on the bottom line of the zero-box upon arrival at atrion.Functional: functional testing was attempted: the device was connected to the pressure indicator and the plunger was pulled outwards to fill the device with distilled water.The device was not able to pull in enough water to be aspirated for functional testing.While aspirating the device was attempted, water began seeping out from the glue plug/clamp area.Atrion disconnected the device from the pressure indicator fixture, removed the clamps and observed that the o-ring underneath was dislocated and blown out of position.The o-ring was removed and noted to contain a familiar deformation, consistent with over pressurization.Atrion replaced the o-ring and re-assembled the device.The device was then connected to the pressure indicator.The device was aspirated and pressurized, and the gauge needle moved accordingly as the pressure was increased.The gauge was found to be out of tolerance at 4 atm, 14 atm and 30 atm.The device passed all other functional testing, which consisted of pressure leak, pressure decay, vacuum capability tests.The device pressurized fully and maintained pressure throughout the functional testing after the clamps and o-ring were replaced.The device passed pressure decay and vacuum capability tests.Also received 2 photo samples.First photo sample shows top view of eagle inflation within packaging.Second photo sample shows top view of outer product packaging.No root cause could be found because the reported event was unconfirmed.A dhr review was not required as the reported event was unconfirmed.A labelling review was not required as the reported event was unconfirmed.Correction: d, f, 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 the balloon dilatation pump leaked during use, making it impossible for the balloon to be inflated and expanded.Per follow up information received on 26jul2024, stated that the balloon was not broken.The pressurized pump leaked so that the balloon could not be expanded.

• 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: 19918484
• Report Number: 1018233-2024-04699
• Device Sequence Number: 20880063
• Product Code: EZN
• UDI-Device Identifier: 10801741052771
• UDI-Public: (01)10801741052771(11)240201(17)260430(10)BMJNFM04
• 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): 01/13/2025

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: BMJNFM04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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