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

Model Number	888504
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Patient Involvement (2645); Insufficient Information (4580)
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 could not be inflated, so another catheter was used.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.A balloon dilation catheter was returned opened with its original packaging.The catheter was found to be burst.The catheter was attached to a 10cc leur lock syringe and water was attempted to be infused.The water leaked out an apparent hole in the dilation balloon.A potential root cause could be due to "inappropriate package 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 balloon inflation: "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." the ifu also states: "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." 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.
Event or Problem Description
It was reported that the balloon could not be inflated.It was also stated that the another catheter was used.As per additional information received via email on 01dec2020 from investigator, it was found that the balloon was torn and per additional information received via email on 01dec2020 from investigator, as the balloon could not be inflated for a balloon dilation catheter.

• 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: 10483190
• Report Number: 1018233-2020-05639
• Device Sequence Number: 3903845
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 01/01/2023
• Device Model Number: 888504
• Device Catalogue Number: 888504
• Device Lot Number: GFDY2995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1