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

Model Number 778426

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem No Code Available (3191)

Event Date 11/18/2019

Event Type  malfunction  

Event Description

The urologist was placing a ureteral stent during an open laparotomy procedure.He had to make a high urethrotomy incision to pass a 5-french angle-tipped ureteral catheter down the ureter into the bladder.Then via cystoscopy, he passed a boston scientific amplatz super stiff straight tip guidewire size 0.035 in.X 145cm wire up the ureter.He then backloaded the wire in the cystoscope and over the top of the wire, placed a 25cm x 4.8 french stent.The stent was placed but went in "very hard" as he felt the wire was bent.When he removed the wire, it broke and unraveled.The stent remained in position.Upon inspection of the wire by the surgeon, he felt it he had all the pieces.An x-ray to confirm this was taken and showed no foreign body in the area except the intended ureteral stent.However, post evaluation by the urologist identified the proximal end of the stent is bent over on itself and will need to be removed at a later date with possible replacement needed in 6-12 weeks.The device involved was the boston scientific amplatz super stiff straight tip guidewire.

• Brand Name: BARD INLAY URETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9382801
• MDR Text Key: 168232908
• Report Number: 9382801
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 778426
• Device Catalogue Number: 778624
• Device Lot Number: NGDR0377
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 71