MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR VL; STENT, URETERAL

Model Number M0061801560

Device Problem Break (1069)

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

Event Date 11/06/2018

Event Type  malfunction  

Event Description

During cystoscopic surgery, a sensor wire was placed by the surgeon into the ureteral orifice and a 5 french ureteral catheter was advanced into the ureteral orifice.A retrograde pyelogram showed moderate to severe hydronephrosis.The 5 french ureteral catheter was advanced up into the renal pelvis and the sensor wire was removed.Renal pelvis urine was clear and was sent for culture.A sensor wire was then readvanced into the renal pelvis and the 5 french ureteral catheter was removed.A 6f vl percuflex stent was attempted to be placed but the tip of stent broke apart/off.The surgeon retrieved all pieces of stent.A new 6f vl percuflex stent was placed over the wire with the proximal curl in the renal pelvis on fluoroscopy and the distal curl in the bladder which was seen under direct vision.Scope was withdrawn and a 16fr foley catheter was placed.Contour vl 6fr.Stent lot #22043520.Manufacturer response for stent, ureteral, contour vl¿ (per site reporter).

• Brand Name: CONTOUR VL
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8174717
• MDR Text Key: 130686728
• Report Number: 8174717
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2018

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: M0061801560
• Device Lot Number: 22043520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA