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

Model Number	997006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Urinary Tract Infection (2120)
Date of Event	05/01/2023
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.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 male pediatric patient (14 years old) experienced perforation and urinary tract infection after placement of the device, these complications were directly attributable to usage of balloon dilation catheter.Perforation was not present prior to placement of the device and did not result in patient injury requiring medical or surgical intervention.Urinary tract infection was present prior to placement of the device, and did result in patient injury requiring medical or surgical intervention such as ureteral scarring.Medical intervention was unknown.
Additional Manufacturer Narrative
The reported event is confirmed use related as the user did not follow the instructions for use and the patient had a urinary tract infection prior to use of device.The potential failure mode is catheter/balloon not biocompatible.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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." 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 male pediatric patient (14 years old) experienced perforation and urinary tract infection after placement of the device, these complications were directly attributable to usage of balloon dilation catheter.Perforation was not present prior to placement of the device and did not result in patient injury requiring medical or surgical intervention.Urinary tract infection was present prior to placement of the device, and did result in patient injury requiring medical or surgical intervention such as ureteral scarring.Medical intervention was unknown.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: BALLOON 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: 16973274
• Report Number: 1018233-2023-03628
• Device Sequence Number: 17804559
• Product Code: EZN
• UDI-Device Identifier: 00801741052194
• UDI-Public: (01)00801741052194
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050875
• 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): 09/25/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 997006
• Device Catalogue Number: 997006
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 09/27/2023
• 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