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

Model Number	131135
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
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.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 in an online survey a physician stated no to the question when they were asked if they were able to successfully insert and remove endoscopes and related instruments.The physician was not able to successfully insert and remove endoscopes and related instruments because physician could not get it up high enough to do that in relation to 131135 - aquaguide® ureteral access sheath ¿ dilator 10fr/sheath diameter 12/14fr, length 35cm.
Event or Problem Description
It was reported that in an online survey a physician stated no to the question when they were asked if they were able to successfully insert and remove endoscopes and related instruments.The physician was not able to successfully insert and remove endoscopes and related instruments because physician could not get it up high enough to do that in relation to 131135 - aquaguide® ureteral access sheath ¿ dilator 10fr/sheath diameter 12/14fr, length 35cm.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.The potential root cause was part geometry; diameter of outer sheath and/or dilator assembly too large/too small.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "directions for use: only physicians trained in use of endoscopic equipment should use this device.A variety of techniques may be employed; however, the physician should use the technique most appropriate for the individual patient¿s situation.1.Activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.2.Place a 0.038¿ guidewire into the ureter using standard endourology techniques.3.Assemble the dilator and sheath together by inserting the dilator into the sheath and rotating the dilator luer.4.Insert the guidewire into the tapered end of the assembly and gradually advance the assembly into the ureter.Note: placement of the assembly can be verified using fluoroscopy or radiographic means.5.Once placed, a safety wire can be placed or a contrast media injected into the ureter using the side lumen.6.Rotate the dilator luer and remove the dilator and, if desired, the initial guidewire.7.An endoscope and/or related instruments can now be used with the ureteral conduit.8.If desired, irrigation and/or aspiration can be applied through the side lumen.Note: to optimize visibility, make sure the access sheath tip is close to the area that requires additional irrigation." 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: AQUAGUIDE® 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: 17316083
• Report Number: 1018233-2023-05124
• Device Sequence Number: 6116039
• Product Code: FED
• UDI-Device Identifier: 00801741052569
• UDI-Public: (01)00801741052569
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K033778
• 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): 10/16/2023

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: 131135
• Device Catalogue Number: 131135
• 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: 10/24/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/26/2023
• 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