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

Model Number	996081
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
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 device was not returned.
Event or Problem Description
It was reported that when using the balloon dilation catheter, the insufflator presented a sudden water and pressure leakage.They stated that it did not cause harm to the patient, but caused difficultly in carrying out the procedure.
Event or Problem Description
It was reported that when using the balloon dilation catheter, the insufflator presented a sudden water and pressure leakage.They stated that it did not cause harm to the patient, but caused difficultly in carrying out the procedure.
Additional Manufacturer Narrative
The reported event is inconclusive since no sample was returned.A potential root cause for this event could be, "poor design" or "physician error".The device was not returned for evaluation.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: "only a physician who has an understanding of the clinical applications, technical principles and associated risks associated with balloon dilation of the nephrostomy tract should use this device." "carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident." "warning: do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media." "note: the use of an inflation device with a pressure gauge is highly recommended to make sure adequate pressure is applied and the maximum limits of the balloon are not exceeded." "note: slight reduction in balloon pressure may be required if resistance is encountered when advancing the sheath over the balloon." "caution: do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded.Please refer to the device label for the recommended rbp." the device was not returned.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12923640
• Report Number: 1018233-2021-07716
• Device Sequence Number: 5476000
• Product Code: LJE
• UDI-Device Identifier: 10801741127653
• UDI-Public: (01)10801741127653
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: 04/25/2022
• Device Model Number: 996081
• Device Catalogue Number: 996081
• Device Lot Number: BMDWFM23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2019
• 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