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

Model Number	998006
Medical Device Problem Codes	Fluid/Blood Leak (1250); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
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 when expanding the balloon with an inflation device, the pressure could not be maintained at all after raising it to the required pressure and locking it.It was caused due to the contrast medium leaking from the flanger part of the inflation device, and even if the pressurization was continued after that, it idled and no pressure was applied.Due to the leakage of the contrast medium in the inflation device, it was refilled and pressurized, and the three-way stopcock was locked to maintain the pressurization, and there was no problem with the case itself.Per follow-up information received via ibc on 21apr2022, stated that there was no impact to the patient.
Additional Manufacturer Narrative
The reported event is confirmed, supplier manufacturing related.Photo samples were submitted by the customer which shows some liquid on/in the device, however the reported event could not be confirmed based on the photo.The eagle inflation device was returned with the balloon dilation catheter.An evaluation of the physical sample was completed by holly parsons of atrion medical.The gauge needle was in the zero position when the sample was received.No visual anomalies were noted.The root cause for this event would be error in manufacturing.The device was used for treatment purposes.The device history record was reviewed.No manufacturing issues or non-conformances were noted in the dhr review that could have caused or contributed to the reported event.Based on the results of the investigation no additional action is required at this time.A label/pack review is not required as a review of the label could not have prevented the reported event.The actual/suspected device was inspected.
Event or Problem Description
It was reported that when expanding the balloon with an inflation device, the pressure could not be maintained at all after raising it to the required pressure and locking it.It was caused due to the contrast medium leaking from the flanger part of the inflation device, and even if the pressurization was continued after that, it idled and no pressure was applied.Due to the leakage of the contrast medium in the inflation device, it was refilled and pressurized, and the three-way stopcock was locked to maintain the pressurization, and there was no problem with the case itself.Per follow-up information received via ibc on 21apr2022, stated that there was no impact to the patient.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14281051
• Report Number: 1018233-2022-03255
• Device Sequence Number: 17823660
• Product Code: EZN
• UDI-Device Identifier: 10801741052801
• UDI-Public: (01)10801741052801
• 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): 07/19/2022

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: 12/30/2023
• Device Model Number: 998006
• Device Catalogue Number: 998006
• Device Lot Number: BMFUFM26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: Male