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

Model Number	996081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematuria (2558); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in an online survey, a physician stated a tissue trauma (hematuria, bleeding) adverse event, directly attributable to the device 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile.Also stated that the patient experienced uti prior to device 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile placement and didn't result in patient injury requiring medical or surgical intervention.It was unknown what medical intervention was provided.
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 in an online survey, a physician stated a tissue trauma (hematuria, bleeding) adverse event, directly attributable to the device 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile.Also stated that the patient experienced uti prior to device 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile placement and didn't result in patient injury requiring medical or surgical intervention.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be coating/tissue incompatibility.A dhr review is not required as no lot number was provided.The instructions for use were found adequate and state the following: "warnings: 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." correction: g,f,h 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.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY 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: 16961139
• Report Number: 1018233-2023-03598
• Device Sequence Number: 5391851
• Product Code: LJE
• UDI-Device Identifier: 10801741127653
• UDI-Public: (01)10801741127653
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063632
• 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): 09/18/2023

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: 996081
• Device Catalogue Number: 996081
• 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: 09/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 09/22/2023
• 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