MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RENAL SHEATH

Model Number 992081

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

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 when they questioned that did x-force renal sheath¿s radiopaque marker provide adequate visibility and the physician stated no the radiopaque marker did not provide adequate visibility for the device 992081 - x-force® 8mm x 17cm renal sheath, clear, sterile because of difficult access and local anatomy.

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 material selection.The dhr review is not required as no lot number was reported.The instructions for use were found adequate and states the following: precautions: · only a physician who has an understanding of the clinical applications, technical principles and risks associated with balloon dilation of a nephrostomy tract should use this device.Directions for use: establishment of a percutaneous nephrostomy tract and renal dilation should always be performed under fluoroscopic control.1.Percutaneous access is established and a guidewire passed into a secure location within the intra-renal system.If feasible, the guidewire should be passed down the ureter and into the bladder.2.Dilation of the tract to the desired size should be performed using an x-force¿ nephrostomy balloon dilation catheter.3.Once the tract is established, the sheath is passed over the dilation device and positioned as desired.4.Remove the dilation instrument from within the sheath, maintaining both the sheath and guidewire in position.5.The guidewire may now be secured in the guidewire notch.6.The procedure may now be performed through the sheath.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.

Event Description

It was reported that in an online survey when they questioned that did x-force renal sheath¿s radiopaque marker provide adequate visibility and the physician stated no the radiopaque marker did not provide adequate visibility for the device 992081 - x-force® 8mm x 17cm renal sheath, clear, sterile because of difficult access and local anatomy.

• Brand Name: BARD® RENAL SHEATH
• Type of Device: RENAL SHEATH
• 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: 17190751
• MDR Text Key: 317753051
• Report Number: 1018233-2023-04628
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00801741095023
• UDI-Public: (01)00801741095023
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080944
• 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: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 992081
• Device Catalogue Number: 992081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/07/2023
• 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