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

Model Number	888504
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
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 burst during pretest.
Event or Problem Description
It was reported that the catheter balloon burst during pretest.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.The evaluation of the returned dilation catheter sample showed that the catheter balloon was damaged.The device failed to meet specifications.The device was being used for treatment.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: ¿device description: the uroforce® balloon dilation catheter is a dual-lumen catheter with a nydex* balloon mounted on its distal tip and with two radiopaque markers beneath the balloon that define working length.The lumen labeled ¿balloon¿ is for balloon inflation.The other lumen allows the catheter to track over a 0.038¿ (.97mm) diameter guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.Each balloon inflates to a stated diameter and length at a specific pressure--typically at 10 atm.The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a profile reducing sheath that is positioned over the balloon for protection before use.A stylet is inserted in the distal (guidewire) lumen beneath the balloon to prevent kinking during shipment and storage.Indications for use: uroforce® balloon dilation catheters are recommended for dilation of the urinary tract.Contraindications: do not use the uroforce® balloon dilation catheter to treat obstruction that is due to extrinsic factors.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.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of device, which may lead to device failure, and/or lead to injury, illness or death of the patient.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.Directions for use: 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." h11:section a through f - the information provided by bd 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 bd.

• Brand Name: UROFORCE® BALLOON DILATION CATHETER
• Common Device Name: UROFORCE BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9480277
• Report Number: 1018233-2019-08013
• Device Sequence Number: 16223041
• 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): 02/13/2020

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: 07/01/2022
• Device Model Number: 888504
• Device Catalogue Number: 888504
• Device Lot Number: GFDT1065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1