MAUDE Adverse Event Report: COOK INC UNKNOWN; FAD STENT, URETERAL

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This occurred in two different cases with different patients.In both cases the tethers broke off.For the first case, the physician placed the stent and then continued to do a resection or cauterization of the patient's urethra after the stent placement.The tether was still attached at the time.The tether later broke sometime after the patient left the hospital.The physician initially thought that he might have damaged the tether during the resection or cauterization process but later reconsidered after a second tether break was reported (1820334-2015-00823).A second stent was placed in a different patient and the tether was extending out normally.The patient called the facility a few days after the procedure to report that the tether had broken and had come out on its own (1820334-2015-00824).The stents had to be removed with flexible forceps and a cystoscope from the bladder.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), manufacturing instructions, quality control and trends was conducted during the investigation.No product or photos were returned to assist with this investigation.The device is inspected to ensure that the tether has proper placement, suture, and a secure knot there is no evidence to suggest that the device was not manufactured to specification.The ifu details: "the stent may be removed easily by gentle withdrawal traction using endoscopic forceps." based on the information provided, the root cause is unable to be determined or reported at this time.We will continue to monitor for similar complaints.

Event Description

This occurred in two different cases with different patients.In both cases the tethers broke off.For the first case, the physician placed the stent and then continued to do a resection or cauterization of the patient's urethra after the stent placement.The tether was still attached at the time.The tether later broke sometime after the patient left the hospital.The physician initially thought that he might have damaged the tether during the resection or cauterization process but later reconsidered after a second tether break was reported (1820334-2015-00823).A second stent was placed in a different patient and the tether was extending out normally.The patient called the facility a few days after the procedure to report that the tether had broken and had come out on its own (1820334-2015-00824).The stents had to be removed with flexible forceps and a cystoscope from the bladder.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: UNKNOWN
• 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: 5263489
• MDR Text Key: 32592054
• Report Number: 1820334-2015-00823
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• 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
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/14/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other