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

Model Number 778626

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

Event Type  malfunction  

Event Description

Patient with diagnosis of left ureteral stone and right renal stone undergoing cystoscopy, bilateral retrograde pyelograms, left ureteroscopy with holmium laser lithotripsy, stone extraction, and double-j stent placement with shockwave lithotripsy.During the procedure, the physician was pushing the stent in the patient's ureter when the stent split at the distal end of the stent.The stent was removed and a new stent was placed.There was no patient harm nor injury.Defective stent information: inventory item: stent ureteral inlay 6fx26cm, model/cat no.: 778626, implant name: stent ureteral inlay 6fx26cm, laterality: right, area: ureter, manufacturer: bard, action: wasted, number used: 1, implant type: stent, reason wasted: defective, lot no.: ngbw1183, expiration date: 10/10/2022.

• 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: 7609715
• MDR Text Key: 111391622
• Report Number: 7609715
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/10/2022
• Device Model Number: 778626
• Device Catalogue Number: 778626
• Device Lot Number: NGBW1183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 88 YR