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

Model Number 996081

Device Problem Device Handling Problem (3265)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/09/2023

Event Type  Injury  

Event Description

It was reported that in an online survey a physician stated a perforation adverse event, directly attributable to the device 995081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, sterile.Also stating that the patient with the device 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile placement did result in patient injury requiring medical or surgical intervention because forced dilatation.As per follow up information received via mail on 14jun2023, in an online survey, a physician stated a perforation adverse event, directly attributable to the device 995081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, sterile.Physician also indicated 'perforation' was present prior to device placement.Also stating that the patient with the device 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile placement did result in patient injury requiring medical or surgical intervention because forced dilatation.

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.

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 inadequate pressure applied to inflate balloon.The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: "only a physician who has an understanding of the clinical applications, technical principles and associated risks associated with balloon dilation of the nephrostomy tract should use this device.The x-force® nephrostomy 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.Preparation of the catheter: all x-force® nephrostomy balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated.Remove the protective sheath from the balloon.Attach the inflation device to the connector on the balloon lumen.Open the stopcock, and draw back on the inflation device to remove the air from the balloon catheter.Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the balloon catheter.Repeat steps 3-4 until all air is removed from the balloon lumen." inflating the balloon catheter.Fill the inflation device (eagle¿ inflation device) with sterile, liquid media.Attach the inflation device to the balloon lumen.Open the stopcock and inflate the balloon." once dilation has been attained, advance the sheath over the balloon.Warning: do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media.Note: the use of an inflation device with a pressure gauge is highly recommended to make sure adequate pressure is applied and the maximum limits of the balloon are not exceeded.Note: slight reduction in balloon pressure may be required if resistance is encountered when advancing the sheath over the balloon.Caution: 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 rbp." 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 perforation adverse event, directly attributable to the device 995081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, sterile.Also stating that the patient with the device 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile placement did result in patient injury requiring medical or surgical intervention because forced dilatation.Per follow up information received via mail on 14jun2023, critical care nurses reported in an online survey that a perforation adverse event, directly attributable to the device 995081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, sterile.Physician also indicated 'perforation' was present prior to device placement.Also stating that the patient with the device 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile placement did result in patient injury requiring medical or surgical intervention because forced dilatation.

• 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: 17265985
• MDR Text Key: 318463450
• Report Number: 1018233-2023-04924
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10801741127653
• UDI-Public: (01)10801741127653
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/30/2023

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?: Yes
• 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: 06/14/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 11/06/2023
• 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): Required Intervention