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

Model Number 996101

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  malfunction  

Event Description

It was reported that the balloon in the dilation catheter was pinched.The customer had to open a new balloon and then it worked fine.Stated the product was defective and no impact to the patient.The balloon was pinched in the middle while inflating during a percutaneous nephrolithonomy.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned.A potential root cause for this event could be, "poor balloon design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "preparation of the catheter all x-force® nephrostomy 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." "inflating the balloon catheter 1.Fill the inflation device (eagle¿ inflation device) with sterile, liquid media.2.Attach the inflation device to the balloon lumen.3.Open the stopcock and inflate the balloon.4.Once dilation has been attained, advance the sheath over the balloon." the device was not returned.

Event Description

It was reported that the balloon in the dilation catheter was pinched.Customer had to open a new balloon and then it worked fine.Stated the product was defective and no impact to the patient.The balloon was pinched in the middle while inflating during a percutaneous nephrolithonomy.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13010764
• MDR Text Key: 283785919
• Report Number: 1018233-2021-08095
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10801741127660
• UDI-Public: (01)10801741127660
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: 996101
• Device Catalogue Number: 996101
• Device Lot Number: BMFVFM42
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other