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

Model Number 996081

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematuria (2558); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2023

Event Type  Injury  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 315548810
• Report Number: 1018233-2023-03598
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 996081
• Device Catalogue Number: 996081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other