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

Model Number	887410
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
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.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 device was not returned.
Event or Problem Description
It was reported that a physician stated in an online survey that they were not able to successfully sustain and/or monitor pressure with the eagle inflation device.Stated that the uroforce balloon dilation catheter with eagle inflation device was not successful in sustaining and/or monitoring pressure because of lack of nursing staff experience.
Event or Problem Description
It was reported that a physician stated in an online survey that they were not able to successfully sustain and/or monitor pressure with the eagle inflation device.Stated that the uroforce balloon dilation catheter with eagle inflation device was not successful in sustaining and/or monitoring pressure because of lack of nursing staff experience.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be "user lacks appropriate training".The dhr review is not required as no lot number was reported.The instructions for use were found adequate and states the following: contraindication: none.Warnings: ¿ use only liquid inflation media.Do not inflate with air.¿ always follow the manufacturer¿s directions accompanying the balloon dilation catheter for instructions for use, maximum balloon inflation pressure, precautions, and warnings for that device.¿ this is a single use device.Do not re-sterilize 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 the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable regulations.Precaution: ¿ before use, inspect the device to verify that no damage has occurred during shipping and handling.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Instructions for use: preparation: make all aspiration and injection maneuvers with the lock lever pushed left, i.E., unlocked.Unlock the piston by pushing the lock lever left.In this position, you can freely pull the piston back for aspiration, or push it forward for injection.To lock the piston in position, slide the lever right to the straight up position.1.Prepare a solution of contrast medium and normal saline in a small sterile bowl or in the well provided with the package.Check balloon catheter and contrast medium instructions for specific contrast mixture recommendations.2.Orient the tubing downward into the contrast medium.3.Push the release lever left and aspirate enough solution to fill the syringe.4.Hold the device upright to purge the air from the syringe and connecting tube.Tap the syringe lightly, if necessary, to remove all the air bubbles and fill the connecting tube completely.5.Inspect the syringe and tubing to ensure that the device has been completely purged.6.Adjust the syringe volume to 3 to 4cc.If more contrast solution is needed, submerge the syringe tip into the basin of solution and aspirate.Attaching the inflation device to the balloon dilation catheter: 1.Prepare and test the balloon dilation catheter according to the manufacturer¿s directions for use.2.If a separate syringe was used to prepare the balloon catheter, remove it.Create a fluid-fluid connection between the balloon and the connecting tube (male rotating adapter) of the inflation device by placing a drop of contrast solution from the syringe into each hub.3.Hand tighten the hubs securely.Balloon inflation and deflation: 1.Release the lock lever and allow the piston to move forward into neutral position (0 atm).2.To inflate the balloon, engage the lock lever, turn the palm grip on the piston clockwise slowly until the desired inflation pressure is reached.The lock lever maintains the increasing pressure.3.To deflate the balloon, push the lock lever left, releasing the piston, and pull back.Slide the lock lever back to lock, if desired.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 device was not returned.

• Brand Name: UROFORCE® BALLOON DILATION CATHETER
• Common Device Name: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17069888
• Report Number: 1018233-2023-04047
• Device Sequence Number: 12294520
• Product Code: EZN
• UDI-Device Identifier: 10801741052962
• UDI-Public: (01)10801741052962
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K993840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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 Model Number: 887410
• Device Catalogue Number: 887410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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