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

Model Number	998604
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
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 water could not be injected into the foley catheter balloon and inflation failed.
Additional Manufacturer Narrative
The reported event is confirmed, supplier manufacturing related.The x-force balloon dilation catheter was returned without the original packaging.An evaluation was completed.Visual evaluation noted no occlusions or irregularities in the balloon hub, portholes or outer shaft.Functional testing was performed introducing a 0.038" guidewire through the wire hub.An attempt was then made to fill the catheter balloon with distilled water using an inflation device but was not successful.A second attempt was made to inflate the balloon, it was able to be inflated but took almost a minute to do so.The balloon was then deflated using the inflation device, and that took almost a minute as well.The sample was dissected, and after the y hub was cut, a blockage of glue was observed to be present between the inner and outer shaft, which resulted in the inflation/deflation issues.Per the evaluation results ¿the blockage of glue in the inflation channel could be caused by the misuse of the cannula during the y-hub assembly due to operator distraction.¿ the device was attempted to be used for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that water could not be injected into the foley catheter balloon and inflation failed.

• 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: 15484692
• Report Number: 1018233-2022-07430
• Device Sequence Number: 7755127
• Product Code: EZN
• UDI-Device Identifier: 10801741052702
• UDI-Public: (01)10801741052702
• 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): 02/16/2023

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: 05/15/2023
• Device Model Number: 998604
• Device Catalogue Number: 998604
• Device Lot Number: BMFRFM08
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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