MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT

Model Number 778426

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2023

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 postoperative ureteral stent implantation after ureteral calculus surgery to achieve drainage and support, repeated urgency, dysuria and hematuria after discharge from the hospital.Anti-inflammatory and hemostatic treatment did not improve.Then hospitalization was arranged, re-examination of abdominal ct showed no abnormalities, postoperative ureteral stent implantation to achieve the role of drainage and support, repeated urgency, dysuria and hematuria after discharge from the hospital, anti-inflammatory and hemostatic treatment did not improve significantly, hospitalization was arranged, re-examination of abdominal ct showed no abnormalities, and considering with the placement of stent, the ureteric bladder mucosa was damaged and bleeding and symptoms of urinary tract irritation, the ureteral stent was removed under cystoscopy in advance, the urinary tract symptoms improved.It was unknown what medical intervention was provided.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.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 patient was placed with ureteral stent implantation after ureteral calculus surgery to achieve drainage support.After discharge from hospital, patient experienced repeated urgency, dysuria, and hematuria.Anti-inflammatory and hemostatic treatment did not improve.Then hospitalization was arranged, re-examination of abdominal ct showed no abnormalities, and considering with the placement of stent, the ureteric bladder mucosa was damaged, and bleeding accompanied with symptoms of urinary tract irritation.The ureteral stent was removed under cystoscopy in advance and the urinary tract symptoms improved.Description of event cause analysis is mentioned as hard ureteral stent.Per follow-up information received from ibc on 10mar2023, stated that the repeated urgency, dysuria and hematuria was because the laser damaged the ureteral mucosa during the operation, which caused repeated bleeding after the operation.It was confirmed that the bleeding has no direct relationship with the ureteral stent.

• Brand Name: BARD® INLAY® URETERAL 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16583264
• MDR Text Key: 311684844
• Report Number: 1018233-2023-01918
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014765
• UDI-Public: (01)00801741014765
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 778426
• Device Catalogue Number: 778426
• Device Lot Number: NGGR3430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 07/20/2023
• 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): Required Intervention