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

Model Number	995081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/09/2023
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 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.It was unknown what medical intervention was reported.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.
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.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: ¿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.¿ 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 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.It was unknown what medical intervention was reported.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.

• 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: 17199366
• Report Number: 1018233-2023-04688
• Device Sequence Number: 5580973
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 10/16/2023

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: 995081
• Device Catalogue Number: 995081
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 10/17/2023
• 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