MAUDE Adverse Event Report: COOK UROLOGICAL INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

According to the information provided by the patient's father, the ureteral stent was implanted at (b)(6) on (b)(6) 2015.On (b)(6) 2015, the end of the stent was sticking out of the patient and the (b)(6) emergency room pushed the stent back in.On (b)(6) 2015, the end came out again.The patient was at the physician's office and the doctor pulled it at his office and discovered it had broken.On (b)(6) 2015, the physician tried to remove the ureteral stent at banner thunderbird hospital.He was unable to remove laparoscopically and put in a 2nd stent instead.On (b)(6) 2015, the broken stent was removed by cutting the ureter.It was in 3 pieces.Information from the physician indicated that the patient originally had a stricture in the ureter and the stent was placed.They had to conduct an open surgery to remove the separated stent segment.During the removal, the stent segment broke off in 1-2cm sections and so multiple pieces were removed.They were able to remove all of the stent from the patient and the overall medical outcome was good.

Manufacturer Narrative

(b)(4).Investigation / evaluation a review of the complaint history, documentation, drawing, instructions for use (ifu), manufacturing instructions (mi), quality control (qc) and trends was conducted during the investigation.The expiration date for the provided lot was listed as 05/01/2015.Per information from the customer's statement "the ureteral stent was implanted at on (b)(6) 2015.This indicates that the product was used past its labeled expiration date; which may have been a factor in the fracture of the stent.The provided instructions for use (ifu) precautions "complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to each patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures." and "do not force components during removal or replacement.Carefully remove the components if any resistance is encountered." and "individual variations of interaction between stents and the urinary system are unpredictable." the device is inspected and the stent is wired 100% and the tips are assured to be properly formed and free of flash, debris and discoloration.An inspection is performed to assure proper position, sideport walls, shape and appearance.Medical records were received; which were reviewed and summarized by a reviewer (cook medical science officer).Per his review and summary, the patient had reflex from her bladder to her ureters/kidneys and a surgical repair was performed to stop the reflex.After the surgery a stricture developed in the right ureter.A stent was placed to allow drainage through the stricture.That stent was removed and some residual narrowing of the ureter was noticed.Additional imaging showed swelling of the kidneys from obstruction of urine outflow due to the stricture.At this time the complaint device was placed (4.7 sof-flex stent).The ends were coiled in renal pelvis and bladder at the end of the procedure.When the physician attempted to remove it in the office, it fractured and appeared to have broken at the level of the stricture.Another stent was placed without difficulty.Four months later, an open surgery was needed to remove the remaining stent fragment and repair the stricture.A pre-op ct had shown the ureter was behind the iliac blood vessels and the urologist thought that resulted in external compression which resulted in the development of the stricture.During this procedure, the sigmoid colon was injured; which required a pediatric surgeon to scrub in and repair the colon.Overall the procedure went well and there were no additional records from after the surgery.In conclusion, the cook medical science officer noted that the fractured catheter did not appear to injure the ureter or cause the stricture; this operative procedure was necessary to repair the stricture.It was also needed to remove the catheter, but with or without the fractured catheter this repair was going to be necessary.The root cause of the fracture of the device is unknown, although it most likely was due to an adverse physiological response.Customer stated that the stent came apart in patient, resulting in a percutaneous procedure necessary to remove the entire device.A review of internal documentation did not find any evidence to suggest the product was not made to specification.A definitive root cause can not be determined or reported at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints quality engineering risk assessment (qera) concluded that, no further risk reduction is required.

Event Description

According to the information provided by the patient's father, the ureteral stent was implanted at (b)(6) 2015.On (b)(6) 2015, the end of the stent was sticking out of the patient and the (b)(6) hospital emergency room personnel pushed the stent back in.On (b)(6) 2015, the end came out again.The patient was at the physicians' office and the doctor pulled it at his office and discovered it had broken.On (b)(6) 2015, the physician tried to remove the ureteral stent at another facility ((b)(6) hospital).However, he was unable to remove it laparoscopically and put in a 2nd stent instead.On (b)(6) 2015, the broken stent was removed by cutting the ureter.It was in 3 pieces.Information from the physician indicated that the patient originally had a stricture in the ureter and the stent was placed.They had to conduct an open surgery to remove the separated stent segment.During the removal, the stent segment broke off in 1-2cm sections and so multiple pieces were removed.They were able to remove all of the stent from the patient and the overall medical outcome was good.

• Brand Name: SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5249832
• MDR Text Key: 32109840
• Report Number: 1820334-2015-00804
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 039514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2015
• Device Age: 41 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Patient Age: 3 YR