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

Model Number 995081

Device Problems Burst Container or Vessel (1074); Device Handling Problem (3265)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2020

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 when a doctor was inflating the balloon with a pump, the balloon was split in the middle.Replaced with a new balloon catheter for this patient.

Manufacturer Narrative

The reported event was confirmed as use-related.A dilation balloon catheter was opened inside of its original packaging along with a amplatz sheath.An evaluation was completed by futurematrix interventional (biomerics) and was approved on 27jan2021.The hubs, hub connections, portholes, markers, and shaft were found to be in good condition.The balloon has a circumferential split mid barrel.The inner balloon was also split.The balloon was inspected under 7-20x magnification and the inner split is a clean split.Some of the split portion of the balloon appears to be a clean cut.X-force catheters are 100% inspected for guidewire and leak check during the final manufacturing process.Due to these 100% inspection checks this defected device would not have passed through the production process.According to the supplier evaluation, the reported event was caused by the user.A potential root cause could be due to the user not being appropriately trained on technique.The 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: "carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment".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.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 advance or withdraw the catheter or guidewire against any significant resistance.The cause of the resistance must be determined fluoroscopically and remedial action taken.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." 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.

Event Description

It was reported that when a doctor was inflating the balloon with a pump, the balloon was split in the middle.Replaced with a new balloon catheter for this patient.

• Brand Name: BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10516540
• MDR Text Key: 207514049
• Report Number: 1018233-2020-05800
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715
• 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: 04/05/2021

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: 08/17/2021
• Device Model Number: 995081
• Device Catalogue Number: 995081
• Device Lot Number: BMCXFM15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1