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

Model Number	888504
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
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 the balloon of the catheter could not be inflated during a pretest.
Additional Manufacturer Narrative
The reported event was confirmed.A pin hole was noted about 1.8 inches from the distil end of the device.The balloon would not inflate.A potential root cause could be due to a poor balloon design.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: ¿catheter insertion 1.Prior to use, carefully inspect the catheter for bends, kinks, or other damage which may have occurred during shipment.Do not use the product if damage is evident.2.Dilation procedures may be conducted under fluoroscopic guidance with appropriate x-ray equipment or by direct vision.3.Endoscopically place a 0.038¿ (.97mm) diameter guidewire with the flexible end in the renal pelvis.4.Remove the protective balloon sheath and stylet from the catheter.5.Advance the catheter over the guidewire.6.Use the radiopaque markers located under the balloon to aid in positioning.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.Catheter balloon deflation and removal: 1.Deflate the balloon using a 10cc or larger syringe or inflation device.Since deflation times vary with balloon sizes and shaft lengths, check fluoroscopically to confirm deflation before attempting withdrawal.2.Remove the syringe or inflation device from the catheter allowing ambient pressure to relax the balloon.3.Gently withdraw the catheter.As the balloon starts to exit the endoscope use a smooth, gentle, steady counterclockwise motion to facilitate withdrawal.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.".
Event or Problem Description
It was reported that the balloon of the catheter could not be inflated during a pretest.

• Brand Name: UROFORCE® BALLOON DILATION CATHETER
• Common Device Name: UROFORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8257516
• Report Number: 1018233-2019-00315
• Device Sequence Number: 18873901
• Product Code: EZN
• UDI-Device Identifier: 00801741053122
• UDI-Public: (01)00801741053122
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 01/03/2021
• Device Model Number: 888504
• Device Catalogue Number: 888504
• Device Lot Number: GFCN3996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1