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

Model Number	998010
Medical Device Problem Codes	Inflation Problem (1310); Failure to Infuse (2340)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
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 balloon of the catheter did not inflate when the pressure applied from the inflation device to dilate the balloon.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.A dilation catheter with stopcock and eagle inflation device were received without original packaging.The dilation catheter and eagle inflation device were found to meet specification.The stopcock was broken during the future matrix initial evaluation.A defective stopcock could be a potential root cause for inflation issues.However, the stopcock was unable to be tested as it broke during evaluation.Therefore the reported event was inconclusive.A potential root cause for this failure could be "poor design".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "preparation of the catheter: all x-force® balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated.1.Remove the protective sheath from the balloon.2.Attach the inflation device to the connector on the balloon lumen.3.Open the stopcock and draw back on the inflation device to remove the air from the balloon catheter.4.Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the balloon catheter.5.Repeat steps 3-4 until all air is removed from the balloon lumen." 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.
Event or Problem Description
It was reported that the balloon of the catheter did not inflate when the pressure applied from the inflation device to dilate the balloon.

• 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
• MDR Report Key: 11229145
• Report Number: 1018233-2021-00117
• Device Sequence Number: 17109099
• Product Code: EZN
• UDI-Device Identifier: 10801741052818
• UDI-Public: (01)10801741052818
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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 Model Number: 998010
• Device Catalogue Number: 998010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other