MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 X-FORCE BALLOON DILATION CATHETER, 10MM X 10CM W/INFLATION DEVICE

Catalog Number	998010
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
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 information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that water leakage occurred from the balloon.
Event or Problem Description
It was reported that water leakage occurred from the balloon.
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: "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.".

• Brand Name: X-FORCE BALLOON DILATION CATHETER, 10MM X 10CM W/INFLATION DEVICE
• Common Device Name: X-FORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7910019
• Report Number: 1018233-2018-04438
• Device Sequence Number: 16479731
• Product Code: EZN
• UDI-Device Identifier: 10801741052818
• UDI-Public: (01)10801741052818
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: 998010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1