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

Catalog Number 996081

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/27/2023

Event Type  malfunction  

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.

Event Description

It was reported that during the surgery, when they opened the sterile pack to use balloon dilation catheter and sucked the contrast agent into a syringe with a manometer, it leaked from the top of the syringe.The balloon dilation catheter was not used because there was only one set in stock at the hospital.As per information mentioned in the internal bd comments on 01nov2023, stated that they could not confirm any abnormalities such as cracks or damage on the entire product.

Manufacturer Narrative

The reported event is confirmed cause unknown.It was noted that the gauge needle was in the zero position.Upon device arrival, an unknown white and green substance was found on the inside and outside of the device.The device was connected to the pressure indicator fixture, and an attempt was made to fill the device with distilled water for aspiration.The device was unable to pull in the water, and air coming in through the glue plug / clamp area could be heard.The device was disconnected from the pressure indicator fixture and the clamps were removed.It was noticed that the clamps were separated, and a crack and damage was present on the right clamp.Additionally, the o-ring was dislocated out of its assembled position.Removing the o-ring revealed it to have shifted out of position, and was showing pinch marks as result.Replaced the o-ring and the two clamps with new components, and connected the device back to the pressure indicator fixture to aspirate it.The device aspirated, however the distilled water turned a moss-green color inside the device from the unknown substance present inside the device.The latch was engaged and plunger was rotated clockwise to pressurize the device.After the device o-ring and clamps were replaced, the device passed the pressure leak, pressure decay and vacuum capability test.The device failed the gauge accuracy test, and was found to be out of tolerance.Although an exact root cause could not be determined a potential root cause could be occlusion of fluid path.A dhr review was not required as no lot number was reported.The instructions for use were found adequate and state the following: "description: the bard® eagle¿ inflation device is a one-piece, plastic, 10cc disposable inflation device with a lock lever design that controls the piston, a pressure gauge, and a high-pressure connecting tube with a male rotating adapter.The pressure gauge measures pressures ranging from vacuum to 30 atm; the gauge is marked in 1 atm increments.The gauge also has an inner scale of comparable psi measurements.The accuracy of the pressure gauge has been determined to be within 1 atm over the range.Indications: the inflation device is recommended for use while performing urological balloon dilation procedures to inflate the balloon, sustain pressure, monitor pressure within the balloon, and deflate the balloon.Contraindication: none.Warnings: use only liquid inflation media.Do not inflate with air.Always follow the manufacturer¿s directions accompanying the balloon dilation catheter for instructions for use, maximum balloon inflation pressure, precautions, and warnings for that device.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.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable regulations.Precaution: before use, inspect the device to verify that no damage has occurred during shipping and handling.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Instructions for use: preparation: make all aspiration and injection maneuvers with the lock lever pushed left, i.E., unlocked.Unlock the piston by pushing the lock lever left.In this position, you can freely pull the piston back for aspiration, or push it forward for injection.To lock the piston in position, slide the lever right to the straight up position.1.Prepare a solution of contrast medium and normal saline in a small sterile bowl or in the well provided with the package.Check balloon catheter and contrast medium instructions for specific contrast mixture recommendations.2.Orient the tubing downward into the contrast medium.3.Push the release lever left and aspirate enough solution to fill the syringe.4.Hold the device upright to purge the air from the syringe and connecting tube.Tap the syringe lightly, if necessary, to remove all the air bubbles and fill the connecting tube completely.5.Inspect the syringe and tubing to ensure that the device has been completely purged.6.Adjust the syringe volume to 3 to 4cc.If more contrast solution is needed, submerge the syringe tip into the basin of solution and aspirate.Attaching the inflation device to the balloon dilation catheter: 1.Prepare and test the balloon dilation catheter according to the manufacturer¿s directions for use.2.If a separate syringe was used to prepare the balloon catheter, remove it.Create a fluid-fluid connection between the balloon and the connecting tube (male rotating adapter) of the inflation device by placing a drop of contrast solution from the syringe into each hub.3.Hand tighten the hubs securely.Balloon inflation and deflation: 1.Release the lock lever and allow the piston to move forward into neutral position (0 atm).2.To inflate the balloon, engage the lock lever, turn the palm grip on the piston clockwise slowly until the desired inflation pressure is reached.The lock lever maintains the increasing pressure.3.To deflate the balloon, push the lock lever left, releasing the piston, and pull back.Slide the lock lever back to lock, if desired." 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.

Event Description

It was reported that during the surgery, when they opened the sterile pack to use balloon dilation catheter and sucked the contrast agent into a syringe with a manometer, it leaked from the top of the syringe.The balloon dilation catheter was not used because there was only one set in stock at the hospital.As per information mentioned in the internal bd comments on (b)(6) 2023, stated that they could not confirm any abnormalities such as cracks or damage on the entire product.

• 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 Key: 18159114
• MDR Text Key: 328391748
• Report Number: 1018233-2023-08226
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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 Catalogue Number: 996081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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