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 Abdominal Pain (1685); Pain (1994); Urinary Retention (2119); Hematuria (2558)

Event Date 07/13/2021

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 admitted to the hospital on (b)(6) 2021 due to left lumbar abdominal pain for 2 days worsened for 2 hours and received transurethral holmium laser lithotripsy combined with pneumatic ballistic lithotripsy and left ureteral stent implantation from (b)(6) 2021.Also ureteral stent catheter was indwelled for internal stent drainage.The operation went smooth and the internal stent tube had drained smoothly.Patient was discharged from the hospital on (b)(6) 2021.In the morning of (b)(6) 2021, the patient repeatedly experienced with urinalgia, bright red gross hematuria and sense of urinary insufficiency.From (b)(6) 2021, the patient went to the hospital again.The ureteral stent was completely removed and a small amount of fine gravel powder adhered to its surface with bleeding.Symptomatic treatment such as anti-infection had been given after the operation and symptoms were significantly relieved after the removal of ureteral stents.On (b)(6) 2021, the patient was discharged.

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 refl ux ; stent dislogdgement, fragmentation, migration, occlusion ; fistula formation ; loss of renal function; hemorrhage; pain/discomfort; tent encrustation; hydronephrosis; perforation of kidney, renal; ureteral erosion; infection pelvis, ureter and/or bladder & urinary symptoms" 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 admitted to the hospital on (b)(6) 2021 due to left lumbar abdominal pain for 2 days worsened for 2 hours and received transurethral holmium laser lithotripsy combined with pneumatic ballistic lithotripsy and left ureteral stent implantation (b)(6).Also ureteral stent catheter was indwelled for internal stent drainage.The operation went smooth and the internal stent tube had drained smoothly.Patient was discharged from the hospital on (b)(6).In the morning of july 13, the patient repeatedly experienced with urinalgia, bright red gross hematuria and sense of urinary insufficiency.From (b)(6), the patient went to the hospital again.The ureteral stent was completely removed and a small amount of fine gravel powder adhered to its surface with bleeding.Symptomatic treatment such as anti-infection had been given after the operation and symptoms were significantly relieved after the removal of ureteral stents.On (b)(6), the patient was discharged.

• 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: 12569765
• MDR Text Key: 274542334
• Report Number: 1018233-2021-06174
• 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

• 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: NGEP4412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2020
• 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