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

Model Number 777426

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Irritability (2421); Hematuria (2558)

Event Date 09/01/2021

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 patient was sent to the operating room at 08:25 on (b)(6) 2021 due to multiple stones in the right kidney and the lower part of the right ureter.Later, a ureteral stent was inserted into the right ureter to expand the ureter and prevent postoperative ureteral stenosis and obstruction.The operation went smoothly.The patient complained of obvious pain in the right waist and abdomen during the round at 08:25 on (b)(6) 2021.Also the patient experienced urinary urgency, frequent urination, painful urination, bladder irritation, accompanied by visible hematuria.At 11:46 on (b)(6) 2021, under local anesthesia, the right ureter "ureteral stent" was removed under the cystoscope.During the operation, it was found that some stones were formed at the end of the ureteral stent in the bladder outside the ureter orifice, which adhered to the ureter.Snake venom hemagglutinin was given to stop bleeding on the surface of the end of the stent.After treatment, the symptoms gradually decreased and the patient was discharged from the hospital on (b)(6) 2021.

Event Description

It was reported that the patient was sent to the operating room at 08:25 on (b)(6)2021 due to multiple stones in the right kidney and the lower part of the right ureter.Later, a ureteral stent was inserted into the right ureter to expand the ureter and prevent postoperative ureteral stenosis and obstruction.The operation went smoothly.The patient complained of obvious pain in the right waist and abdomen during the round at 08:25 on (b)(6)2021.Also the patient experienced urinary urgency, frequent urination, painful urination, bladder irritation, accompanied by visible hematuria.At 11:46 on september 2nd, under local anesthesia, the right ureter "ureteral stent" was removed under the cystoscope.During the operation, it was found that some stones were formed at the end of the ureteral stent in the bladder outside the ureter orifice, which adhered to the ureter.Snake venom hemagglutinin was given to stop bleeding on the surface of the end of the stent.After treatment, the symptoms gradually decreased and the patient was discharged from the hospital on september 4.

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 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: "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, ureteral erosion, infection pelvis, ureter and/or bladder, urinary symptoms"."determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.Submerge stent in sterile water to activate the coating." 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.

• 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: 12569756
• MDR Text Key: 274542087
• Report Number: 1018233-2021-06172
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014489
• UDI-Public: (01)10801741014489
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 777426
• Device Catalogue Number: 777426
• Device Lot Number: NGEZ3562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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