MAUDE Adverse Event Report: COOK, INC. BANDER URETERAL DIVERSION STENT SET; GBL CATHETER, URETERAL, GENERAL AND PLASTIC SURGERY

Catalog Number 025707-S1

Device Problem Material Separation (1562)

Patient Problem Surgical procedure, additional (2564)

Event Date 04/30/2014

Event Type  Injury  

Event Description

Bander ureteral diversion stent was transurethrally placed in the ureter of the patient with right kidney cancer prior to laparoscopic nephrectomy.On (b)(6) 2014, when the doctor was removing the stent by grasping with his hand after performing laparoscopic nephrectomy, the stent got separated and the pigtail part was left in the renal pelvis.No wire guide was used.To remove the pigtail part of the stent to approach the renal pelvis, he transurethrally inserted a rigid ureteroscope and found the ureter was ruptured.He made a small abdominal incision and inserted a cystoscope to the ruptured site to remove the pigtail part of the stent.To treat the rupture, a dj stent was placed and the procedure was completed.The patient has been in good condition after the procedure and discharged from the hospital on (b)(6) 2014.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

During investigation, a review of complaint history, instructions for use (ifu), quality control, and a visual inspection was conducted.On (b)(6) 2014, a bander ureteral division stent was transurethrally placed in the ureter of the patient with right kidney cancer prior to a partial nephrectomy of the right kidney.After the completion of the partial nephrectomy, the patient was removing the stent at which point the pigtail separated from the stent and remained in the renal pelvis upon stent removal.In his attempt to retrieve the pigtail portion of the stent, the physician transurethrally placed a rigid ureteroscope and discovered that the ureter had ruptured.The physician made a small abdominal incision and inserted a cystoscope at the ruptured site to remove the pigtail portion of the stent.He then placed a dj stent to treat the rupture.Visual inspection of the device confirmed that each section of the stent at the point of separation was closed.The material appears to have been sliced, causing the separation of the stent, and heated at high temperature to cause the material to melt together forming the closed ends of the stent sections.It is possible that the electrical cautery equipment used to complete the partial nephrectomy severed the stent, thus causing the separation and newly formed closed ends on the sections of the stent.The equipment sliced the stent into two sections while the heat melted the material at the point of separation.The root cause is determined to be a result of product use.The ruptured ureter from this event would be a result of the electrical cautery equipment as well; the bander stent was placed in the right ureter, therefore if the stent has been severed there had to be partial, if not full, tearing of the ureter as well.The reported event stated that the stent separated during the procedure.A visual inspection confirmed that the stent had been severed by the electrical cautery equipment used during the partial nephrectomy.Both ends of the sections at the point of separation were closed; a heated source cut the stent at that point and heated the material so that it melted therefore forming the closed ends seen on the returned product.The stent was placed in the ureter by the physician, therefore the ureter was torn along with the stent by the electrical cautery device during the procedure.The root cause of this event has been determined to be product use - damage caused by another device.The appropriate internal personnel have been notified.Will continue to monitor for similar complaints.

Event Description

Bander ureteral diversion stent was transurethrally placed in the ureter of the patient with right kidney cancer prior to partial nephrectomy of the right kidney.On (b)(6) 2014, when the doctor was removing the stent by grasping with his hand after performing partial nephrectomy of the right kidney, the stent got separated and the pigtail part was left in the renal pelvis.No wire guide was used.To remove the pigtail part of the stent to approach the renal pelvis, he transurethrally inserted a rigid ureteroscope and found the ureter was ruptured.He made a small abdominal incision and inserted a cystoscope to the ruptured site to remove the pigtail part of the stent.To treat the rupture, a dj stent was placed and the procedure was completed.The patient has been in good condition after the procedure and discharged from the hospital on (b)(6) 2014.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Type of Device: GBL CATHETER, URETERAL, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; po box 227; spencer, IN 47460 ; 8123392235
• MDR Report Key: 3877842
• MDR Text Key: 4570935
• Report Number: 1820334-2014-00239
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 025707-S1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention