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

Catalog Number 996081

Device Problems Crack (1135); Use of Device Problem (1670)

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

Event Date 07/15/2019

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 when dilating the occluded ureter with the x-force n30 nephrostomy balloon and injecting water to the balloon using a pump, the connection between the pump and balloon cracked.

Event Description

It was reported that when dilating the occluded ureter with the x-force n30 nephrostomy balloon and injecting water to the balloon using a pump, the connection between the pump and balloon cracked.

Manufacturer Narrative

The reported event was confirmed as use-related.Evaluation report of the returned sample, submitted by atrion medical, states that the right clamp on the device was cracked and broken.The device could not draw in water because the right clamp was broken and the o-ring was out of position.When the right clamp was removed and replaced with a new one, the device passed the functional tests with no anomalies noted, except the out of tolerance gauge due to the gauge needle being off zero upon receipt.Additional evaluation of the components reveals that the plunger exhibited an impact mark and the threads of the halfnut were distorted and damaged.Atrion medical's current manufacturing controls include 100% testing for pressure leakage, pressure decay, vacuum decay, and gauge accuracy during manufacture using ultra high purity nitrogen gas before leaving the facility.At no time is any solution or other substance introduced into the device.Devices that pass this test are marked by automation for identification.Devices that fail are not marked.The returned device was marked, indicating it met manufacturing specifications when it left atrion medical's facility.Atrion medical concludes that a broken clamp, displaced o-ring, damaged plunger and halfnut, and gauge needle outside of the zero position occurs when a device is over-pressurized beyond the pressure capability, in this case 30 atm.Since the device passed full functional testing prior to shipment from the facility and again when new clamps were placed onto the device and the o-ring was repositioned, the root-cause is determined to be user over-pressurization.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "3 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.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.Deflating the balloon catheter deflate the balloon using an inflation device.Since deflation times vary based on balloon sizes and lengths, check fluoroscopically to confirm deflation before attempting to withdraw.1.Attach the inflation device (eagle¿ inflation device) and remove the solution from the balloon by pulling back on the inflation device.2.Remove the inflation device from the balloon catheter.This will allow ambient pressure to enter, relaxing the balloon.3.Gently withdraw the catheter.Use of a gentle counterclockwise twisting motion is recommended when removing the catheter.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.Using the refolding tool the balloon catheter is supplied with a refolding tool.This aids in preparing the balloon for another insertion during the procedure.To use: 1.Manually compress the balloon.2.Position the refolding tool at one end.3.Twist the refolding tool counter clockwise and push down on the balloon until it goes the entire length of the balloon.4.Once the balloon is folded, remove the refolding tool and proceed with the procedure." h11:section a through f - the information provided by bd represents all of 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.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: BARD X-FORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8860697
• MDR Text Key: 153573887
• Report Number: 1018233-2019-04444
• 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: 09/19/2019

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: 08/20/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1