MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER; X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER

Catalog Number 996081

Device Problems Inflation Problem (1310); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2020

Event Type  malfunction  

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 Description

It was reported that it was difficult to inflate the catheter balloon with water using a syringe during the pcnl procedure.

Event Description

It was reported that it was difficult to inflate the catheter balloon with water using a syringe during the pcnl procedure.Per additional information via mail from ibc on 03aug2020, the syringe was directly used to inflate the dilation catheter.

Manufacturer Narrative

The reported event was confirmed as use-related as the event stated that the syringe was directly connected to the dilation catheter.According to the ifu, an inflation device (eagle inflation device) should be used to inflate the catheter.A potential root cause for this issue would be "user does not attach device as indicated".A device history record review was not required as the reported event was confirmed as use-related.The instructions for use were found adequate and state the following: "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.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.".

• Brand Name: BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10135641
• MDR Text Key: 195086736
• Report Number: 1018233-2020-03717
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

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: 10/31/2021
• Device Catalogue Number: 996081
• Device Lot Number: BMDQFM01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1