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

Model Number	998506
Medical Device Problem Codes	Material Fragmentation (1261); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
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.
Event or Problem Description
It was reported that the inflation device of the balloon dilation catheter was broken at the beginning of use.The user stated that the inflation device gave a strange feeling and refrained from using it.The patient used the new balloon dilation catheter, as the user had two bottles ready to go.The new balloon dilation catheter was added to the patient on december 22nd.Only the inflation device was collected.The meter did not go up when the user operated it, and water started leaking when pressure was applied.
Event or Problem Description
It was reported that there was a strangeness in the feeling of the inflation device at the beginning of use, so the customer refrained from using it because it was damaged, and another device was opened.On 22dec2021, the customer added that only the inflation device was collected and stated that even if it was operated, the meter did not rise, and water leaked when pressure was applied.The balloon dilation catheter was not used, but will be returned along with the inflation device.
Additional Manufacturer Narrative
The reported event was confirmed as use related.Photo samples were provided by the customer; one photo showed the gauge needle out of the zero position.Unable to confirm the reported event based on the provided photos.The eagle inflation device and balloon dilation catheter were returned.A white and greenish crystallized substance was present on the outer and inner parts of the device.The gauge needle was bent and not in the zero position.The device was decontaminated and connected to a pressure indicator to aspirate.The plunger was pulled back to fill, the device did not draw water in accordingly and pulled in sufficient air.The latch was engaged, and the plunger was turned clockwise to pressurize the device.As pressure was applied, the device started leaking from the o-ring/clamp area and would not build pressure.The o-ring was removed and replaced with a new one, and then the complaint device was reconnected to the pressure indicator.The device was aspirated and then brought to pressure again.As the pressure was increased the gauge needle increase, due to the gauge needle being bent and out of the zero position, the device failed gauge accuracy testing at 14atm and 30atm.The device passed pressure leak testing, pressure decay and vacuum capability testing with no water or air leakage noted.Atrion's current manufacturing controls include 100% automation testing for pressure leakage, pressure decay, vacuum decay, and gauge accuracy during manufacture using ultra high purity nitrogen gas before leaving the facility.At no time is any solution or other substance introduced into the device.Devices that pass this test are marked by automation for identification; devices that fail are not marked.The returned device was marked, indicating it met manufacturing specifications when it left the facility.The o-ring was found to be dislocated/blown-out from its original assembled position, which allowed air to be pulled in during prep of the device for functional testing and water to leak during testing.A dislocated/blown-out o-ring and gauge needle being off zero can occur when a device is over-pressurized beyond the pressure capability, in this case 30 atm.Since this device passed full functional testing prior to shipment from the supplier facility indicated by the witness mark, the event is confirmed use related.The root cause of this event is determined to be over-pressurization by the user.As the reported event is confirmed use-related, a dhr review is not required.The instructions for use were found adequate and state the following: "do not exceed 30 atm." correction: d, f, h.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 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13157035
• Report Number: 1018233-2021-08680
• Device Sequence Number: 17167605
• Product Code: EZN
• UDI-Device Identifier: 10801741052689
• UDI-Public: (01)10801741052689
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 03/23/2023
• Device Model Number: 998506
• Device Catalogue Number: 998506
• Device Lot Number: BMFNFM19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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