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

Model Number	888604
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
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 balloon dilation catheter was inflated about 15atm, and the balloon got burst.It was replaced with new product.
Event or Problem Description
It was reported that the balloon dilation catheter was inflated about 15atm, and the balloon got burst.It was replaced with new product.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.Unable to determine if the product met specifications due to sample condition.The product was used for treatment purposes.The product had caused the reported failure.A potential root cause for this failure could be inadequate material selection (low pressure material).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.Confirm proper placement of the balloon within the urinary tract.2.Inflate the balloon with standard inflation medium (e.G., diatrizoate meglumine injection u.S.P.60% diluted as appropriate) using a 10cc or larger syringe or inflation device.Note: do not use air or any gaseous substance as a balloon inflation medium.Note: the use of an inflation device to monitor balloon pressure is strongly recommended to determine that adequate pressure is applied and that maximum limits of the balloon are 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 reinflate the balloon.If, upon inspection of the balloon, it is noted that pieces of the balloon are missing, check for and endoscopically retrieve the fragments when possible." h11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.

• Brand Name: UROFORCE BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11154967
• Report Number: 1018233-2020-22445
• Device Sequence Number: 4117446
• Product Code: EZN
• UDI-Device Identifier: 00801741053153
• UDI-Public: (01)00801741053153
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K993840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 888604
• Device Catalogue Number: 888604
• Device Lot Number: GFES1482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other