MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILICONE URETERO-INTESTINAL ANASTOMOSIS URINARY DIVERSION STENT; URETERAL STENT

Model Number 089007

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

It was reported that survey respondent mentioned about dislodgment and urinary tract infection when they were asked of the complications while using the urethral stent.It was unknown what medical intervention was provided.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "material selection/ part geometry".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: "a variety of techniques may be used during stent placement.Each surgeon should use the methods with which he/she is familiar.1.During the surgical procedure, after the ureter has been divided, the stent is straightened by inserting the guidewire into the proximal end (open end) of the stent and advancing it forward to distal end (closed end).2.Pass the stent through the open end of the cut ureter up into the renal pelvis.3.While holding the proximal end, withdraw the guidewire.This will allow the ¿figure 4¿ to form within the renal pelvis thereby ensuring proper placement.4.After isolation of the bowel segment and closure of the distal end have been accomplished, pass a long right angle clamp through the stomal end to the point where the ureter is to be anastomosed.5.Draw the proximal end of the urinary diversion stent through the dissection to the stomal end.6.Palpate the renal pelvis to ensure proper placement of the distal end.7.After the external stoma has been formed, trim the stent so that approximately 5cm protrudes from the stoma.Then attach the stent to the skin with a nonabsorbable suture." h11: section a through f - the information provided by bard represents all of 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 bard.

Event Description

It was reported that survey respondent mentioned about dislodgment and urinary tract infection when they were asked of the complications while using the urethral stent.It was unknown what medical intervention was provided.

• Brand Name: BARD® SILICONE URETERO-INTESTINAL ANASTOMOSIS URINARY DIVERSION STENT
• Type of Device: URETERAL STENT
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14192502
• MDR Text Key: 289959901
• Report Number: 1018233-2022-02902
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741011648
• UDI-Public: (01)10801741011648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K823487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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
• Device Operator: Health Professional
• Device Model Number: 089007
• Device Catalogue Number: 089007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other