MAUDE Adverse Event Report: COOK INCORPORATED BLACK SILICONE; STENT, URETERAL

Model Number G15144

Device Problems Fracture (1260); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/17/2019

Event Type  No Answer Provided  

Event Description

Patient was undergoing a bilateral ureteral stent exchange for a history of retroperitoneal fibrosis.This middle-aged male undergoes bilateral ureteral stent exchanges every 9 months.The previous stent exchange was performed on approximately 8 months ago by the same surgeon.Per the op report, the left system was addressed.A retrograde x-ray was performed.A wire was passed (0.038) then grasped, the curl of the stent and the stent fractured.The surgeon grasped the remaining stent and it fractured once again.The surgeon was concerned that the retroperitoneal process and/or scar and/or calcifications are holding the balance of the stent.The surgeon then took a ureteroscope up the system and did not see any significant calcifications.There was noted an angulation of the ureter just below the ureteropelvic junction (upj) and the curl of the stent was just at the upj.The surgeon tried again to grasp the remaining stent with a basket, but the stent would not move.At that point, the decision was made that the patient would need a left percutaneous nephrostomy in the x-ray department for stent retrieval and antegrade placement of a new stent.Under ultrasound and fluoroscopic guidance, the interventional radiologist (ir) noted partial retrieval of the fractured stent catheter.Manufacturer response for stent, ureteral, black silicone stent (per site reporter).An email notification of this report was sent to our hospital cook medical representatives.

• Brand Name: BLACK SILICONE
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK INCORPORATED; 6300 n. matthews dr.; ellettsville IN 47429
• MDR Report Key: 9551439
• MDR Text Key: 173719132
• Report Number: 9551439
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Model Number: G15144
• Device Catalogue Number: 133622
• Device Lot Number: 9500437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Weight: 114