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

Model Number 089007

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

Patient Problems Micturition Urgency (1871); Post Operative Wound Infection (2446); Hematuria (2558)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the survey respondent mentioned about urgency, hematuria, surgical site infection and dislodgment when asked of complications faced while using the urinary stent.Medical intervention was unknown.

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 was 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 lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿device description: the bard® urinary diversion stent is a stenting catheter made of a radiopaque silicone elastomer.Drainage holes are present at the unique ¿figure 4¿ distal end of the bard® urinary diversion stent and are strategically placed to maximize both strength and required drainage of urine.The bard® urinary diversion stent is provided with a guidewire to facilitate insertion.Indications for use: the bard® urinary diversion stent is intended for use in drainage of urine from the kidney to the external stoma following any uretero-intestinal diversion procedure where the ureter is of sufficient size to allow easy passage of the stent.It is particularly beneficial in those cases where there is poor healing and leakage of the uretero-intestinal anastomosis.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.Improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.3.Exercise care; do not force the guidewire through the distal end of the stent during placement.Tearing of the stent can be caused by sharp instruments.4.Care should be exercised when removing the stent so as not to cause tearing or fragmentation.5.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.Directions for use: 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 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 Description

It was reported that the survey respondent mentioned about urgency, hematuria, surgical site infection and dislodgment when asked of complications faced while using the urinary stent.Medical intervention was unknown.

• Brand Name: BARD® SILICONE URETERO-INTESTINAL ANASTOMOSIS URINARY DIVERSION STENT
• Type of Device: URINARY 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: 14160970
• MDR Text Key: 289686425
• Report Number: 1018233-2022-02725
• 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: 05/10/2022

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: 03/25/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 06/01/2022
• 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