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

Catalog Number	997610
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the surgeon complained that the balloon was not deflating completely when it was time to remove the balloon from the ureter following dilation.Upon testing, the balloon deflated normally.The bard sales rep.Stated the issue stemmed from the fact that the user (the scrub tech) was not waiting long enough for the vacuum effect to take full effect.In order to deflate the balloon, the inflator should be deployed back fully to allow the pressure to pull all of the fluid out of the balloon and deflate it.Final conclusion was that the product was working properly and this event was a user error.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿description the x-force® balloon dilation catheter is a dual lumen catheter with a balloon mounted on the distal tip.It has a radiopaque tip and two radiopaque markers beneath the balloon that define the working length.The lumen labeled with the rated burst pressure (xx atm) 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 the infusion of medication and/or contrast medium.Each balloon inflates to a stated diameter and length at a specific pressure, typically 10 atm.The x-force® balloon dilation catheter comes packaged with a refolding tool and is available with or without an inflation device.It comes sterile and is for single use only.Indications for use the x-force® balloon dilation catheter is recommended for use in the dilation of the urinary tract.Contraindications do not use the x-force® balloon dilation catheter in the presence of conditions, which create unacceptable risk during the dilation of the urinary tract.Warnings ¿ do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded.Please refer to the device label for the recommended maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.¿ 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.Precautions caution: federal law (u.S.A.) restricts this device to sale by or on the order of a physician.Only a physician who has an understanding of the clinical applications, technical principles and associated risks of balloon dilation within the urinary tract should use this device.After use, the x-force® balloon dilation catheter and/or accessories may be considered a potential biohazard.Handle and dispose of in accordance with medical practice and applicable laws and regulations.Inspection prior to use the x-force® balloon dilation catheter is a sterile, single use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident.Preparation of the catheter all x-force® balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated.1.Remove the protective sheath from the balloon.2.Attach the inflation device to the connector on the balloon lumen.3.Open the stopcock and draw back on the inflation device to remove the air from the balloon catheter.4.Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the balloon catheter.5.Repeat steps 3-4 until all air is removed from the balloon lumen.Catheter insertion 1.Introduce the catheter carefully over a 0.038¿ (.97mm) guidewire and place it in the area that needs to be dilated.Use the radiopaque markers to aid in proper positioning.Note: dilation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment or direct vision.Caution: do not advance or withdraw the catheter or guidewire against any significant resistance.The cause of the resistance must be determined fluoroscopically and remedial action taken.X-force® balloon dilation catheter".
Event or Problem Description
It was reported that the surgeon complained that the balloon was not deflating completely when it was time to remove the balloon from the ureter following dilation.Upon testing, the balloon deflated normally.The bard sales rep.Stated the issue stemmed from the fact that the user (the scrub tech) was not waiting long enough for the vacuum effect to take full effect.In order to deflate the balloon, the inflator should be deployed back fully to allow the pressure to pull all of the fluid out of the balloon and deflate it.Final conclusion was that the product was working properly and this event was a user error.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: URETERAL BALLOON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8120912
• Report Number: 1018233-2018-05697
• Device Sequence Number: 252652
• Product Code: EZN
• UDI-Device Identifier: 00801741052118
• UDI-Public: (01)00801741052118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050875
• 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): 02/07/2019

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 Catalogue Number: 997610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1