MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PROXIS¿ URETERAL ACCESS SHEATH

Catalog Number	231045
Medical Device Problem Codes	Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There were a lot of cases where the guidewire would not go through because there was something like glue remaining on the connection between the hub of the dilator and the gray dilator.In many cases, it would go through if pressed it hard and repeatedly, and medicon claims that this was a defect.Lot #bmjrfm14 and lot #unk.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿equipment error".However, there was insufficient information to confirm this potential root cause.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "indications for use: the proxis ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.Contraindications: patients who are contraindicated for retrograde urological procedures.Patients who are contraindicated for antegrade urologic procedures, including but not limited to patients with blood clotting anomalies due to coagulopathies or pharmacological anticogagulations.Patients who have the presence of tight strictures which would limit use of the device.Patients who have the presence of large obstructing distal ureteral calculi.Warning: for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/ or lead to device failure, which in turn, may result in patient injury, illness or death.Reuse reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Do not use if sterile barrier is damaged.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Precautions: the recommendations given are meant to serve only as a basic guide to the utilization of this access sheath.The ureteral access sheath should not be used without comprehensive knowledge of the indications, techniques and risks of the procedure.To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.Do not advance sheath without the dilator in place as this could lead to trauma or injury to patient.Do not bend the device prior to placement as this could damage the integrity of the device and result in patient injury.Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Adverse events: potential adverse events associated with the use of the transurethral access device include, but are not limited to: mucosal irritation, inflammation and edema, urethral strictures, acute bleeding or hemorrhage, urethral, bladder, or ureteral perforation, other injury to the urinary tract".Udi format updated with available product information per gudid.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 or Problem Description
It was reported that there were a lot of cases where the guidewire would not go through because there was something like glue remaining on the connection between the hub of the dilator and the gray dilator.In many cases, it would go through if pressed it hard and repeatedly, and medicon claims that this was a defect.Lot# bmjrfm14 and lot# unk.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The labeling was reviewed and found to be adequate.A dhr could not be performed since no lot number was provided.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that there were a lot of cases where the guidewire would not go through because there was something like glue remaining on the connection between the hub of the dilator and the gray dilator.In many cases, it would go through if pressed it hard and repeatedly, and medicon claims that this was a defect.Lot#bmjrfm14 and lot# unk.
Event or Problem Description
It was reported that there were a lot of cases where the guidewire would not go through because there was something like glue remaining on the connection between the hub of the dilator and the gray dilator.In many cases, it would go through if pressed it hard and repeatedly, and medicon claims that this was a defect.Lot#bmjrfm14 and lot#unk.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: e, f, h udi format updated with available product information per gudid.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.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: URETERAL ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 20137505
• Report Number: 1018233-2024-05501
• Device Sequence Number: 7482807
• Product Code: FED
• UDI-Device Identifier: 00801741101694
• UDI-Public: (01)00801741101694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/17/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 231045
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 07/14/2025; 07/17/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/18/2024; 07/15/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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