MAUDE Adverse Event Report: C. R. BARD, INC. BARD INLAY OPTIMA MULTILENGTH STENT; STENT, URETERAL

Model Number 788600

Device Problem Difficult to Remove (1528)

Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Swelling (2091)

Event Date 08/21/2019

Event Type  Injury  

Event Description

Procedure was cystoscopy with left retrograde pyelogram, attempted left ureteral stent.Fluoroscopy showed the wire and the stent coiled in the renal pelvis.The wire was started to be removed; however, it caused crumpling of the stent, and under fluoroscopy as the wire was being removed, the stent appeared to be bending and pleating over the wire, but was not disengaging from the wire.Several attempts were made to pull the wire out of the stent, and it would not disengage.Ultimately, the wire and stent were removed en bloc through the penis.Because the wire appeared to have been embedded and engaged halfway through the stent, the stent was cut.Another attempt was made to thread a wire through this stent using a hydrophilic wire, but unfortunately, the tip of the remaining stent was in the bladder and had already disengaged the ureteral orifice.The cystoscope was then replaced.It was clear that the process of removing the stent had caused considerable swelling and edema around the left ureteral orifice which was also bleeding.The pt was admitted to observation and for placement of a percutaneous nephrostomy tube.Fda safety report id(s)# (b)(4).

• Brand Name: BARD INLAY OPTIMA MULTILENGTH STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 8965899
• MDR Text Key: 158626792
• Report Number: MW5089588
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: 788600
• Device Catalogue Number: 788600
• Device Lot Number: NGCX2396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 75