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

Model Number	997706
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
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.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.The device was not returned.
Event or Problem Description
It was reported that during the process of inflation, leakage occurred at the balloon of the ureteral dilation balloon catheter and the user replaced it with a new catheter.It was mentioned that an extra operation or drug therapy was included for this incident.As per the follow up information received via ibc on (b)(6) 2022, it was stated that the event included extra operation or drug therapy refers to the catheter replacement.
Additional Manufacturer Narrative
The reported event is confirmed, supplier related.No physical sample was returned, however, a four second video was submitted.An evaluation of the video sample was completed.The video showed a healthcare provider holding the dilation catheter on the outer shaft next to the proximal end of the balloon and a leak was noted.The video also showed another healthcare provider using a twisting motion while the leak was occurring, assuming due to the use of an endoflator which cannot be seen.The origin of the leak cannot be determined due to the short video, lack of angling, and the absence of a physical sample.The pressure used cannot be determined as the endoflator is out of the video.A potential root cause for this event could be, "inadequate test procedures/lack of training".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was 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 during the process of inflation, the contrast agent leakage occurred at the balloon of the ureteral dilation balloon catheter and the user replaced it with a new catheter.It was mentioned that extra operation or drug therapy was included for this incident.Per follow up information received via ibc on 07apr2022, it was stated that the event included extra operation or drug therapy refers to the catheter replacement.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14189599
• Report Number: 1018233-2022-02868
• Device Sequence Number: 4481397
• Product Code: EZN
• UDI-Device Identifier: 00801741052132
• UDI-Public: (01)00801741052132
• 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): 09/15/2022

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: 11/24/2023
• Device Model Number: 997706
• Device Catalogue Number: 997706
• Device Lot Number: BMFSFM08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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