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

Model Number 089007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503)

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "material selection".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "contraindications: there are no known contraindications to use.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Precautions: 1.For single use only.Do not resterilize.Do not use if package or product is damaged.For urological use only 2.Choice of stent size and duration of indwelling time are at the discretion of the physician.All stents may be subject to varying degrees of encrustation when placed in the urinary tract.Periodic checks of the stent by cystoscopic and/or radiographic means are recommended.When, at any time during the indwelling duration, encrustation is of sufficient severity that there is potential for occlusion of the stent or the patient experiences pain or discomfort which the physician determines to be associated with the presence of the stent, or if there is indication of infection in the area of the stent, the stent should be removed and, if the patient¿s condition permits, replaced with a new stent".

Event Description

It was reported that the survey respondent mentioned about urgency, urinary tract infection, irritative urinary symptoms and incomplete emptying when asked of complications while using the ureteral stent.It was unknown what medical intervention was provided.

• Brand Name: BARD® SILICONE URETERO-INTESTINAL ANASTOMOSIS URINARY DIVERSION STENT
• Type of Device: URINARY DIVERSION 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15437272
• MDR Text Key: 300037045
• Report Number: 1018233-2022-07188
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741011648
• UDI-Public: (01)10801741011648
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K823487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2022

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
• 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: 04/13/2022
• Initial Date FDA Received: 09/16/2022
• 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