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

Catalog Number 787624

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the black tip part of the ureteral catheter got detached and remained in the patient kidney during the stent replacement.The doctor 's opinion was that the ureter was possibly compressed by a malignant tumor, but since the patient had experiences using the device, and that the ureter would not be that narrowed and there was no resistance.The black tip part of the ureteral catheter was confirmed in the kidney by computerized tomography (ct) but could not be removed immediately considering the patient's condition and needed an early response as the adhesion defect was suspected.Per follow up on (b)(6) 2020, the tip was confirmed to be remained in the kidney by computerized tomography (ct) but could not be removed immediately considering the patient's condition.Not obtained additional information of removal of the tip.

Event Description

It was reported that the black tip part of the ureteral catheter got detached and remained in the patient kidney during the stent replacement.The doctor 's opinion was that the ureter was possibly compressed by a malignant tumor, but since the patient had experiences using the device, and that the ureter would not be that narrowed and there was no resistance.The black tip part of the ureteral catheter was confirmed in the kidney by computerized tomography (ct) but could not be removed immediately considering the patient's condition and needed an early response as the adhesion defect was suspected.Per follow up on (b)(6) 2020, the tip was confirmed to be remained in the kidney by computerized tomography (ct) but could not be removed immediately considering the patient's condition.Not obtained additional information of removal of the tip.

Manufacturer Narrative

The reported event was confirmed as supplier related issue.Evaluation found breakage at the tip of the tigertail.However, the broken tip was not returned for evaluation.The reported event which is related to material fragmentation is considered as part of defective component issue.The potential root cause for this failure mode could be, ¿defects component from supplier¿.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: "precautions for use ureteral catheter (1) when using the tigertailtm ureteral catheter, especially without the stabilizing support of a guidewire, be aware that a malfunction may occur where the flexible tip may detach if excessive force is made in contact with the walls of the bladder, ureter or renal pelvis.Should the flexible tip portion of the catheter become detached, retrieve with an endourology grasping device.(2) do not withdraw the ureteral catheter while it is deflected in endoscope.(3) avoid sharp bending of the ureteral catheter.(4) when performing drainage of urine, retrograde visualizations etc.Though the ureteral catheter, attach the ureteral catheter adapter to the tip of ureteral catheter.(5) do not over-tighten the catheter adapter.Over-tightening of the catheter adapter may occlude the lumen of the catheter.(2) ureteroarterial fistula may be formed between the ureter and the aorta of the iliac artery and result in massive hemorrhage at the replacement of the ureteral stent if a ureteral stent is placed for a long term in a patient who has undergone the intrapelvic surgery or irradiation.Therefore, carefully monitor the condition of the patient, and in the event of acknowledging bleeding from the urethra, perform retrograde pyelography or angiography, and provide appropriate care." correction: b.H11:section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10711458
• MDR Text Key: 212299657
• Report Number: 1018233-2020-20267
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Catalogue Number: 787624
• Device Lot Number: MYER0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention