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

Model Number	998806
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
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 x-force inflation port leaked during inflation.The leak point was allegedly at the junction of the port and the pressure pump.
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: "[warnings] - method of use: 1.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 rbp.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.2.Do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media.3.If resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to the product.Applying excessive force to the catheter can result in tip breakage or balloon separation." 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.H3 other text : tehe device was not returned.
Event or Problem Description
It was reported that the x-force inflation port leaked during inflation.The leak point was allegedly at the junction of the port and the pressure pump.
Additional Manufacturer Narrative
The reported event was confirmed as use-related.The evaluation report of the returned sample, submitted by atrion medical, noted that during functional testing of the device, it pulled in air at the clamp / o-ring area, which prevented the device from drawing in enough water to become pressurized.The clamps were removed from the device, and it was noted that the o-ring was out of position.When the o-ring was removed and replaced with a new one, the device was within tolerance and passed all functional testing.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: ¿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 patient 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 patient 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." corrections: d4.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 x-force inflation port leaked during inflation.The leak point was allegedly at the junction of the port and the pressure pump.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: NON-VASCULAR BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8309998
• Report Number: 1018233-2019-00639
• Device Sequence Number: 2137839
• Product Code: EZN
• UDI-Device Identifier: 10801741052771
• UDI-Public: (01)10801741052771
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2019

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 Expiration Date: 04/30/2020
• Device Model Number: 998806
• Device Catalogue Number: 998006
• Device Lot Number: BMBVFM46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/28/2019; 06/24/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 04/19/2019; 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1