MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); No Code Available (3191)

Event Date 07/07/2015

Event Type  Injury  

Event Description

During a ureteroscopy procedure, the stent was placed with no issues.However, when the tether was being removed from the bladder, the physician snipped the tether and during the attempt to pull the tether string, it broke.At that point the broken end was removed and the portion that was connected to the stent was left in the patient during the procedure.Another manufacturer's laser was used during this procedure and it was noted that it was a very large stone.Afterwards, the portion of the tether that broke off was removed from the patient's urethra and bladder.It is unknown what type of instrument was used to removed it.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not required any additional procedures nor experience any adverse effects after to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, documentation, drawing, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The tether was not returned; therefore no physical evaluation could be conducted.Review of lot history shows no non-conformances for the provided lot and there is no evidence to suggest products from this lot were not manufactured in accordance to the current specification.The instructions for use for universa® stent soft or firm cautions: ¿complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.¿ ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ it is possible that the user exerted excessive force when removing the stent from the patient.Based on the available information, a definitive root cause cannot be established.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.

Event Description

During a ureteroscopy procedure, the stent was placed with no issues.However, when the tether was being removed from the bladder, the physician snipped the tether and during the attempt to pull the tether string, it broke.At that point the broken end was removed and the portion that was connected to the stent was left in the patient during the procedure.Another manufacturer's laser was used during this procedure and it was noted that it was a very large stone.Afterwards, the portion of the tether that broke off was removed from the patient's urethra and bladder.It is unknown what type of instrument was used to remove it.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects after to this occurrence.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4961770
• MDR Text Key: 6190207
• Report Number: 1820334-2015-00447
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2018
• Device Model Number: N/A
• Device Catalogue Number: USH-626-R
• Device Lot Number: 5869875
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2015
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2015
• 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