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

Model Number	887604
Medical Device Problem Codes	Partial Blockage (1065); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
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 dilation catheter balloon was malfunctioning.Per additional information received via email on 01-feb-2022, it was reported that the dilation catheter balloon would not inflate.Customer stated that no medical concerns related to the reported issue.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.2 dilation catheters were returned opened without original packaging.Catheters were marked 1 and 2 during evaluation to differentiate.Using a eagle inflation device both catheter balloons were attempted to be inflated with di water.Catheter 1 would not allow any water to be injected into the catheter.Catheter 2 inflated without issue.The inflation lumen of catheter 1 appeared to be blocked as no water would pass through.As the cause of the blockage is unknown, the reported event will be confirmed cause unknown.Catheter does not meet specification as it was unable to inflate.The sample was observed under microscope.No blockage was noted.Destructive testing was performed and the inflation valve was cut off.Water flowed freely through the inflation valve when the catheter shaft was cut off.No kink was noted in the catheter shaft.Inflation difficulty caused by a blockage of the catheter shaft.Sample was cut longitudinally.A clear substance was found in a portion of the catheter shaft.The substance is the cause of the blockage.The complaint is confirmed for the reported event of difficult to inflate, the root cause is a foreign substance in the inflation lumen.The product was used for treatment purposes.A potential root cause for this failure could be "inadequate material selection".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: 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." 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 the dilation catheter balloon was malfunctioning.Per additional information received via email on 01-feb-2022, it was reported that the dilation catheter balloon would not inflate.Customer stated that no medical concerns related to the reported issue.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13596354
• Report Number: 1018233-2022-00869
• Device Sequence Number: 1989337
• Product Code: EZN
• UDI-Device Identifier: 10801741053006
• UDI-Public: (01)10801741053006
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: 09/01/2022
• Device Model Number: 887604
• Device Catalogue Number: 887604
• Device Lot Number: GFEN1281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2020
• 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