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

Model Number 996081

Device Problem Burst Container or Vessel (1074)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the balloon was burst.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "marker bands damage balloon".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: "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".The user guide currently contains instruction that would assist in preventing potential user related causes of reported issue." the device was not returned.

Event Description

It was reported that the balloon was burst.

• Brand Name: BARD X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10656446
• MDR Text Key: 210637716
• Report Number: 1018233-2020-20031
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10801741127653
• UDI-Public: (01)10801741127653
• 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: 05/03/2021

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: 11/09/2022
• Device Model Number: 996081
• Device Catalogue Number: 996081
• Device Lot Number: BMDRFM29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other