MAUDE Adverse Event Report: COOK MEDICAL, INC. 8.5F NEPHRO URETERAL STENT 24CM

Catalog Number 648176

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Pain (1994); Hematuria (2558)

Event Date 05/18/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, interventional radiology placed a nephroureteral stent with an "[invalid]".On (b)(6) 2016 the patient underwent a left ureteroscopy with laser lithotripsy in the operating room.The nephroureteral stent was removed.The "[invalid]" was not removed as the urologist was not aware there was an "[invalid]" attached to the stent and the md did not see an "[invalid]" ureteral stent was placed.The second stent was removed in the clinic in (b)(6) 2016.Post procedure the patient became symptomatic with hematuria, infection, micro-hematuria, pressure in his kidney area, and occasional left flank pain.The patient was treated with antibiotics and exams were done such as kub and ct of abdominal organs, kidney, ureter, and bladder.On (b)(6) 2016 the patient saw urologist #2.A ct urogram of the abdomen and pelvis with and without contrast was ordered.Results revealed: a thin contiguous linear opacity extending from the lower calyces of the left kidney to the mid/distal ureter felt to be latrogenic in etiology, possibly reflecting suture material related to prior intervention.On (b)(6) 2016 the patient underwent a cystoscopy, left ureteroscopy with removal foreign body [nylon "[invalid"], and placement of left ureteral stent.

• Brand Name: 8.5F NEPHRO URETERAL STENT 24CM
• Type of Device: 8.5F NEPHRO URETERAL STENT 24CM
• Manufacturer (Section D): COOK MEDICAL, INC. ; bloomington IN 47402
• MDR Report Key: 6503143
• MDR Text Key: 73272354
• Report Number: MW5069177
• Device Sequence Number: 1
• Product Code: FAD
• 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: 04/17/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2018
• Device Catalogue Number: 648176
• Device Lot Number: 6369777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2017
• 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: 55 YR
• Patient Weight: 92