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

Model Number	887610
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
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.The device was not returned.
Event or Problem Description
It was reported that there was a leak in a dilation catheter balloon.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The used balloon dilation catheter was returned in the opened original packaging.Visual evaluation noted some inflation medium present in the balloon along with some crystal like sediment.The balloon itself felt "crisp" to touch and flakes were noted to be falling off/out of the balloon.Although a specific cause cannot be determined, a potential root cause for this event could be, "poor balloon design".No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warnings: do not exceed the recommended maximum balloon inflation pressure that is stated on the label.Extreme caution should be used when considering dilation of irregular, non-compliant tissue or in the presence of certain calculi." "precautions: this device should be used only by a physician who has an understanding of the clinical applications, technical principles and associated risks of balloon dilation within the urinary tract." "catheter balloon inflation: 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." "caution: if resistance is felt when either removing the guidewire from the catheter or the catheter from the endoscope, stop and consider removing them as a single unit to prevent damage to the product or tissue trauma.Applying excessive force to the catheter can result in tip breakage or balloon separation." correction: d,f,g,h h11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that there was a leak in a dilation catheter balloon.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15417843
• Report Number: 1018233-2022-07098
• Device Sequence Number: 6618905
• Product Code: EZN
• UDI-Device Identifier: 10801741053020
• UDI-Public: (01)10801741053020
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K993840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 06/01/2025
• Device Model Number: 887610
• Device Catalogue Number: 887610
• Device Lot Number: GFGS1697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown