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

Model Number	887504
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Tissue Damage (2104); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
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 burst.The patient's ureter was damaged and required temporary stenting.
Additional Manufacturer Narrative
The reported event was confirmed.The sample was received open and without original packaging and with the inflation device.An opening in the balloon was observed, which measured 0.622 inches longitudinally.The opening gaped 0.600 inches at rest.No pieces appeared to be missing.The device was connected to the inflation device and initiated.All inflation volume leaked from the balloon.The lot number is unknown therefore the device history record could not be reviewed.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" correction:concomitant medical products and device evaluated by mfr.
Event or Problem Description
It was reported that the balloon of the catheter burst.The patient's ureter was damaged and required temporary stenting.

• Brand Name: UROFORCE® BALLOON DILATION CATHETER
• Common Device Name: UROFORCE BALLOON
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8378347
• Report Number: 1018233-2019-01078
• Device Sequence Number: 16891294
• Product Code: EZN
• UDI-Device Identifier: 10801741052979
• UDI-Public: (01)10801741052979
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Non-Healthcare 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 887504
• Device Catalogue Number: 887504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 02/28/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention