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

Model Number	998706
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the leak of contrast occurred at the balloon dilation catheter during the process of inflation and then replaced with a new device.It was mentioned that an extra operation or drug therapy was included for this incident.As per the follow-up information received on (b)(6) 2022, there was no sample available and a new catheter was replaced.
Additional Manufacturer Narrative
The reported event was confirmed, supplier related.No physical sample was returned, however, a 49 second video sample 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 at the distal cone.The video partially showed another healthcare provider using an endoflator to inflate the balloon.The pressure used cannot be determined as the endoflator was out of the video.A potential root cause for this event could be, "inadequate test procedures/lack of training".The device was used for treatment purposes.It was unknown if the device had met all relevant specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling/packaging review was not required as the labeling could not have prevented the reported failure.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 the leak of contrast occurred at the balloon dilation catheter during the process of inflation and then replaced with a new device.It was mentioned that an extra operation or drug therapy was included for this incident.As per the follow-up information received on 07apr2022, a new catheter was replaced.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14189473
• Report Number: 1018233-2022-02866
• Device Sequence Number: 17244858
• Product Code: EZN
• UDI-Device Identifier: 10801741052740
• UDI-Public: (01)10801741052740
• 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): 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/30/2023
• Device Model Number: 998706
• Device Catalogue Number: 998706
• Device Lot Number: BMFSFM30
• 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: 09/12/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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: Required Intervention; Other
• Patient Sex: Unknown