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

Model Number 777626

Device Problem Biocompatibility (2886)

Patient Problems Urinary Frequency (2275); Hematuria (2558); Dysuria (2684)

Event Date 08/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 5 days after the surgery, the patient presented symptoms of urgency, frequency of urination, pain in urine and bladder irritation, accompanied by gross hematuria and blood clots when ureteral stent was used.On (b)(6), the patient went to the surgical clinic, and was advised to rest in bed, drink more water, and drip 250ml levofloxacin lactate sodium chloride injection.On (b)(6), all the symptoms disappeared.On (b)(6) patient again impacted with greater urgency, frequent urination, urinary pain, and bladder irritation symptoms associated with visible to the naked eye hematuria, on that day to this hospital surgical residents.On (b)(6) for patients with urethral pull out under cystoscope ureteral stent indwelling right ureter, had given postoperatively ceftriaxone sodium for injection 2.0 g add sodium chloride injection intravenous drip in 100 ml, for twice a day, the patient's uncomfortable symptoms gradually relieved and disappeared.

Manufacturer Narrative

The reported event is inconclusive since no sample was returned.A potential root cause for this event could be, "material selection".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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." "potential complications: potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema ¿ stone formation ¿ peritonitis ¿ extravasation ¿ ureteral reflux ¿ stent dislogdgement, fragmentation, migration, occlusion ¿ fistula formation ¿ loss of renal function ¿ hemorrhage ¿ pain/discomfort ¿ stent encrustation ¿ hydronephrosis ¿ perforation of kidney, renal pelvis, ureter and/or bladder¿ ureteral erosion ¿ infection ¿ urinary symptoms" h11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that on august 27, 5 days after the surgery, the patient presented symptoms of urgency, frequency of urination, pain in urine and bladder irritation, accompanied by gross hematuria and blood clots when ureteral stent was used.On august 28, the patient went to the surgical clinic, and was advised to rest in bed, drink more water, and drip 250ml levofloxacin lactate sodium chloride injection.On august 30, all the symptoms disappeared.On august 30 the patient again impacted with greater urgency, frequent urination, urinary pain, and bladder irritation symptoms associated with visible to the naked eye hematuria, on that day to this hospital surgical residents.On august 31 for patients with urethral pull out under cystoscope ureteral stent indwelling right ureter, had given postoperatively ceftriaxone sodium for injection 2.0 g add sodium chloride injection intravenous drip in 100 ml, for twice a day, the patient's uncomfortable symptoms gradually relieved and disappeared.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12647394
• MDR Text Key: 276877583
• Report Number: 1018233-2021-06454
• 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: 03/15/2022

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 Expiration Date: 09/12/2023
• Device Model Number: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGCZ3358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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
• Patient Age: 52 YR
• Patient Sex: Male