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

Model Number	998010
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the catheter balloon was difficult to inflate during pretest.
Event or Problem Description
It was reported that the catheter balloon was difficult to inflate during pretest.
Additional Manufacturer Narrative
The reported event is unconfirmed.The sample evaluation was completed on 11aug2020.A sample was received inside sterilization pouch inside ziploc bag with sterilization label.The catheter sample was visual inspected at normal room lighting 12-18" from eye with no visual defects seen.The catheter sample was also checked under 7-20x magnification with no issues seen.An inhouse 0.038" guidewire was inserted into the catheter and it passed with no issues.The guidewire was left in place and a new 10cc inflation device was attached to the balloon hub, the catheter was inflated with no issues and held inflation at rated burst pressure (30atm) for 10 minutes.The device was inflated and deflated an additional 5 time with no functional defects.The process engineer repeated the inflation/deflation process and no issues were found.As the device was able to be inflated, there does not appear to be a relationship between the reported event and the device.The device for the same reason would be considered to meet specification as it was able to inflated a rated burst pressure.As the device, according to the ifu, can be used "for monitoring of pressure" or "infusion of medication and/or contrast medium" it is unknown based on the event whether the device was used for treatment of diagnosis.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: "do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded." the ifu also contains the following inflation instructions: "inflating the balloon catheter 1.Fill the inflation device (eagle¿ inflation device) with sterile diluted contrast medium.2.Attach the inflation device to the balloon lumen.3.Inflate the balloon note: do not use air or any gaseous substances as a balloon inflation medium 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 rated burst pressure of the balloon is not exceeded.Caution: if loss of pressure in the balloon occurs or the balloon ruptures, immediately stop the procedure, deflate the balloon and remove carefully.Do not attempt to re-inflate the balloon.If after inspection it is noted pieces of the balloon are missing, check for and endoscopically retrieve the fragments when possible.Warning: 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 maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.".

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: URETERAL BALLOON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10227797
• Report Number: 1018233-2020-04280
• Device Sequence Number: 536536
• Product Code: EZN
• UDI-Device Identifier: 10801741052818
• UDI-Public: (01)10801741052818
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 998010
• Device Catalogue Number: 998010
• Device Lot Number: BMCUFM04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1