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

Model Number	231125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932)
Date of Event	06/26/2023
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 : the device was not returned.
Event or Problem Description
It was reported that in the online survey a physician stated that the patient experienced inflammation, ureteral perforation prior to the device placement and inflammation, hemorrhage complications were directly attributable to the device and technical error was needed for hemorrhage in relation to 231125 - proxis¿ ureteral access sheath - outer dilator 11 fr/sheath diameter 13fr, length 25cm.No medical intervention was reported.
Event or Problem Description
Critical care nurses reported in an online survey that the patient experienced inflammation, ureteral perforation prior to the device placement and inflammation, hemorrhage complications were directly attributable to the device and technical error was needed for hemorrhage in relation to 231125 - proxis¿ ureteral access sheath - outer dilator 11 fr/sheath diameter 13fr, length 25cm.No medical intervention was reported.
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 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: 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 anticoagulants.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.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.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.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: 17358097
• Report Number: 1018233-2023-05315
• Device Sequence Number: 17777931
• Product Code: FED
• UDI-Device Identifier: 00801741212741
• UDI-Public: (01)00801741212741
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160861
• 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): 10/11/2023

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: 231125
• Device Catalogue Number: 231125
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/16/2023
• 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