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

Model Number	231145
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/27/2023
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.
Event or Problem Description
It was reported that when inserting and withdrawing the endoscope, it caught the inside of the ureteral access sheath.Also stated that patient felt discomfort during use.No medical intervention was reported.
Event or Problem Description
It was reported that when inserting and withdrawing the endoscope, it caught the inside of the ureteral access sheath.Also stated that patient felt discomfort during use.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned for evaluation and further investigation was not conclusive.Though a specific cause cannot be determined, a potential root cause for this event could be, "material selection".Unable to complete a dhr review as the lot number is unknown.The instructions for use were found adequate and state the following: "the proxis ureteral access sheath instructions for use, was reviewed and found to be adequate as it states: "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." "directions for use: 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.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.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.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.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.If desired, irrigation can be applied using the luer connector on the dilator.Upon completion of the access procedure, gently withdraw the device.Discard the device in accordance with hospital procedures and with applicable laws and regulations." 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.

• 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 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: 16590062
• Report Number: 1018233-2023-01930
• Device Sequence Number: 2970242
• Product Code: FED
• UDI-Device Identifier: 00801741212765
• UDI-Public: (01)00801741212765
• 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
• Report Date (Section B): 06/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 231145
• Device Catalogue Number: 231145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/26/2023
• 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