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

Model Number	995081
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
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 balloon of the balloon dilation catheter was found to be broken during use.A new one was replaced to complete the procedure.The patient was safe.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned and further investigation was not conclusive.Although a specific cause cannot be determined, potential causes for this event could be, poor balloon design (molecular orientation, wall thickness), inadequate material selection, contact with stone, damage from sheath, improper fiber orientation.The device was used for treatment purposes.It was unknown if the device had met all relevant specifications or resulted in the reported event.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 states the following: the x-force® nephrostomy balloon dilation catheter instructions for use, baw0309767 revision 1, was reviewed and found to be adequate as it states: "if resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to the product.Applying excessive force to the catheter can result in tip breakage or balloon separation." "this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." "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." "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." "warning: if resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to product.Applying excessive force to the catheter can result in tip breakage or balloon separation." 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 device was not returned.
Event or Problem Description
It was reported that balloon of the balloon dilation catheter was found to be broken during use.A new one was replaced to complete the procedure.The patient was safe.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16183603
• Report Number: 1018233-2023-00125
• Device Sequence Number: 19498490
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: TW
• PMA/510(K) Number: K063632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: 11/18/2024
• Device Model Number: 995081
• Device Catalogue Number: 995081
• Device Lot Number: BMGRFM27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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