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

Model Number 777626

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Skin Discoloration (2074); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/29/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, when the patient was admitted to the hospital, a ureteral stent was placed at 10:30 and the patient had no discomfort after the placement.On (b)(6) 2023, at 8:30, the patient complained of discomfort at the urethral opening.After examination, the doctor found that the patient's urethra was red and swollen, and there was a little sticky secretion.The doctor ordered normal saline and povidone iodine to wipe the urethral opening, and adjusted the medication, and closely observed if the patient continued to develop fever, chill and other symptoms.Since the patient's primary disease was urinary tract infection, so it could not be determined if the reaction was related to that.

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.H3 other text : the device was not returned.

Event Description

It was reported that on (b)(6) 2023, when the patient was admitted to the hospital, a ureteral stent was placed at 10:30 and the patient had no discomfort after the placement.On (b)(6) 2023, at 8:30, the patient complained of discomfort at the urethral opening.After examination, the doctor found that the patient's urethra was red and swollen, and there was a little sticky secretion.The doctor ordered normal saline and povidone iodine to wipe the urethral opening, and adjusted the medication, and closely observed if the patient continued to develop fever, chill and other symptoms.Since the patient's primary disease was urinary tract infection, so it could not be determined if the reaction was related to that.

Manufacturer Narrative

The reported event is confirmed inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be material selection.The dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and states the following: precautions: for single use only.Do not re-sterilize.Do not use if the package or product is damaged.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.Suture may be cut off prior to stent placement.Remove suture prior to placement for pediatric patients.Exercise care.Tearing of the stent can be caused by sharp instruments.Ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.The insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure.Multi-length ureteral stents: formation of knots in multi-length ureteral stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal.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.H3 other text: the device was not returned.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: 17135980
• MDR Text Key: 317246220
• Report Number: 1018233-2023-04365
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGGP1626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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