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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER Back to Search Results
Catalog Number 996081
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2024
Event Type  malfunction  
Event Description
It was reported that a percutaneous nephrolithotomy was performed on (b)(6) 2024.After opening the package of balloon dilation catheter, the doctor found that the gauge of the pressure pump was disconnected and fell off, so they replaced it with a new product and performed the operation.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
 
Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted one inflation device was returned to atrion inside a zip lock bag with the inflator tray.Upon receipt of the complaint device a visual inspection was conducted.During the visual inspection, it was noted that the gauge was broken from the inflation device housings at the glue plug area.The needle on the gauge was also noted to be within the zero position.Also received 1 photo sample which shows top overview of eagle inflation device.Based on physical sample received the product does not meet specifications.A potential root cause for this type of failure could be inappropriate package design.However, there was insufficient information to confirm this potential root cause.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: "instructions for use caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Description the x-force® nephrostomy balloon dilation catheter is a dual lumen catheter with a 24 (8mm) or 30fr (10mm) balloon mounted on the distal tip.It has a radiopaque tip and a radiopaque marker beneath the balloon.The lumen labeled with rated burst pressure (xx atm) is for balloon inflation.The other lumen allows the catheter to track over a 0.038¿ (.97mm) diameter guidewire and can be used for monitoring of pressure or the infusion of medication and/or contrast medium.Each balloon inflates to a stated diameter and length at a specific pressure ¿ typically at 10 atm.The balloon dilation catheter comes packaged with a refolding tool and a working sheath.It is available with or without an inflation device.It comes sterile and is for single use only.Indications for use the x-force® nephrostomy balloon dilation catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.Contraindications do not use the x-force® nephrostomy balloon dilation catheter in the presence of conditions which create unacceptable risk during the dilation of the nephrostomy tract.Warnings: ¿ 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.¿ do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media.¿ 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.Precautions: ¿ 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.¿ after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable laws and regulations." 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 Description
It was reported that a percutaneous nephrolithotomy was performed on (b)(6) 2024.After opening the package of balloon dilation catheter, the doctor found that the gauge of the pressure pump was disconnected and fell off, so they replaced it with a new product and performed the operation.
 
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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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18630222
MDR Text Key334426571
Report Number1018233-2024-00417
Device Sequence Number1
Product Code LJE
UDI-Device Identifier10801741127653
UDI-Public(01)10801741127653
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K962611
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/29/2024
2 Devices were Involved in the Event: 1   2  
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 Catalogue Number996081
Device Lot NumberBMGTFM33
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/15/2024
Initial Date FDA Received02/02/2024
Supplement Dates Manufacturer Received04/30/2024
Supplement Dates FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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