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

Catalog Number	231125
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the dilator lock broke as a surgeon was grasping it and tried to separate it from the sheath.
Event or Problem Description
It was reported that the dilator lock broke as a surgeon was grasping it and tried to separate it from the sheath.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.No actions can be taken at this time since a root cause was not identified.Visual evaluation noted the sample was provided inside a large ziploc bag.Visual requirements state to use unaided eye at 12 to 18 distances under normal room lighting.Upon evaluation of the sample, it was observed that one of the clasps of the locking mechanism had detached from the hub.The dilator was removed from the sheath without hesitation.When performing the dhr review there were no reports of the broken hubs or failure of the locking mechanism.Dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: instructions for use description: the proxis ureteral access sheath is a two component ureteral dilation system which contains a single lumen for injection of fluids as well as passage of endoscopes and related instruments.The packaged product includes the following items: 1 - hydrophilic-coated dilator with female luer connector 1 - hydrophilic-coated sheath with hub 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.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.Directions for use: 1.Activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.Place an 0.035 (0.889mm) or 0.038 (0.965mm).Guidewire into the ureter using standard endourology techniques.2.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.3.Insert the guidewire into the tapered end of the dilator/sheath assembly and gradually advance the assembly into the ureter.Note: placement of the assembly can be verified using fluoroscopy or radiographic means.4.While maintaining sheath position, disengage the dilator lock from the sheath hub to gently remove the dilator.Do not advance sheath without the dilator in place.Note: suture holes are provided on sheath hub for securing externally, if desired.5.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.6.If desired, irrigation can be applied using the luer connector on the dilator.7.Upon completion of the access procedure, gently withdraw the device.8.Discard the device in accordance with hospital procedures and with applicable laws and regulations.Correction: d, e, 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21547850
• Report Number: 1018233-2025-01538
• Device Sequence Number: 12526420
• Product Code: FED
• UDI-Device Identifier: 00801741212741
• UDI-Public: (01)00801741212741(11)230524(17)260516(10)BMHSFM06
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: Other
• Device Expiration Date: 05/16/2026
• Device Catalogue Number: 231125
• Device Lot Number: BMHSFM06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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