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

Model Number	998604
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Perforation (2001); Tissue Damage (2104)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
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 after inflating and deflating the catheter, the patient allegedly experienced a longitudinal tear of about one centimeter in the back section of the ureter.The extent of intervention that was performed to repair the ureter is currently unknown.
Event or Problem Description
It was reported that after inflating and deflating the catheter, the patient allegedly experienced a longitudinal tear of about one centimeter in the back section of the ureter.They informed the ministry of health.The extent of the intervention is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation.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." 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 : the device was not returned.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: X-FORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8598774
• Report Number: 1018233-2019-02423
• Device Sequence Number: 11262559
• Product Code: EZN
• UDI-Device Identifier: 10801741052702
• UDI-Public: (01)10801741052702
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 998604
• Device Catalogue Number: 998604
• Device Lot Number: BMBXFM09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 DA