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

Catalog Number 786624

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Date 10/18/2017

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 the patient allegedly developed ureter stenosis on the 3rd day of placement.The user noted that there seems to have been an allergic reaction.The symptom subsided after the stent was replaced with a silicone made stent.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: method of used: when using the multi-length type of stent, it should be avoided in the following cases.If you measure the length of patient's ureter stent which has different shape of tip and length.Ureteral stents with excessive coil parts have risked of knot formation at the tip of renal pelvis side during placement or removal.If any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during removal may lead to damage of the renal pelvis and/or ureter.Ureteroarterial fistula may be formed between the ureter and the aorta or 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." the device was not returned.

Event Description

It was reported that the patient allegedly developed ureter stenosis on the 3rd day of placement.The user noted that there seems to have been an allergic reaction.The symptom subsided after the stent was replaced with a silicone made stent.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7346290
• MDR Text Key: 102711598
• Report Number: 1018233-2018-00823
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

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 Catalogue Number: 786624
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention