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

Model Number	998606
Medical Device Problem Codes	Gas/Air Leak (2946); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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 desired pressure was not reached due to air leak in the pump of the balloon dilation catheter.
Event or Problem Description
It was reported that the desired pressure was not reached due to air leak in the pump of the balloon dilation catheter.
Additional Manufacturer Narrative
The reported event was confirmed as use-related.Three photo samples were provided by the customer showing the dilation catheter and inflation device, however, no evidence of leakage was noted on the photos.The x-force balloon dilation catheter and eagle inflation device were returned with the original packaging.The needle gauge was not in the zero position when the device was received.Functional testing was performed; the device was connected to a pressure indicator and an attempt was made to fill the device with distilled water and aspirate it.The device would not draw in sufficient water and air could be heard leaking from the device.The clamp was removed for further evaluation, and it was found that the o-ring was out of position.The blown o-ring was replaced, and the device was connected to a pressure indicator, aspirated and functionally tested.The latch was engaged, and the plunger was rotated clockwise to pressurize the device.The gauge accuracy test was performed on the device, and it failed at the 4atm, 14atm, and 30atm areas due to the gauge needle being off zero upon receipt.The device underwent pressure leak test, the pressure decay test, and the vacuum capability test.The device passed these functional tests with no anomalies noted.During all functional testing, the complaint device pressurized accordingly, and the gauge increased as pressure was applied to the device, although it was out of tolerance.The blown o-ring allowed air to be pulled in during the prepping of the device for functional evaluation; therefore, the device was unresponsive.A blown o-ring, and gauge needle out of the zero position occur when a device is over-pressurized beyond the pressure capability, in this case 30 atm.Since the device passed full functional testing prior to shipment from the supplier facility and again when the dislocated o-ring was replaced on the device, this event is confirmed use-related.The device history record review was not performed as the reported event was confirmed use-related.The instructions for use were found adequate and state the following: the inflation gauge which states "do not exceed 30 atm".Correction: h.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: X-FORCE URETERAL DILATION BALLOON 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: 11922298
• Report Number: 1018233-2021-03195
• Device Sequence Number: 14431102
• 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): 12/14/2021

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: 04/25/2022
• Device Model Number: 998606
• Device Catalogue Number: 998606
• Device Lot Number: BMDXFM06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• 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: Male