MAUDE Adverse Event Report: COOK INC KWART RETRO-INJECT URETERAL STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problem Knotted (1340)

Patient Problems Nonresorbable materials, unretrieved in body (2276); No Code Available (3191)

Event Date 01/12/2015

Event Type  Injury  

Event Description

The (b)(6) year old female patient was having an ureteroscopy with laser lithotripsy, stone removal and stent placement procedure.The stent was placed by the physician on (b)(6) 2015; however, it was later determined that the stent had tied itself in a knot in the renal pelvis of the kidney.They attempted to pull out the stent percutaneously on (b)(6) 2015 but was unsuccessful.The complaint device currently remains inside of the patient's body.An additional procedure will occur at later date to remove the stent.

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), quality control, and specifications was conducted during the investigation.No product was returned for evaluation, therefore no physical examination could be completed.No evidence to suggest product was not manufactured to specifications.The ifu cautions to evaluate periodically via cystoscopic, radiographic, or ultrasonic means.It also cautions individual variations of interaction between stents and the urinary system are unpredictable.Improper handling can seriously weaken the stent.Do not force components during removal or replacement.Due to the device not being returned, a root cause can not be determined.Per the conclusion of quality engineering risk assessment, no further risk reduction is required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

The (b)(6) year old female patient was having an ureteroscopy with laser lithotripsy, stone removal and stent placement procedure.The stent was placed by the physician on (b)(6) 2015; however, it was later determined that the stent had tied itself in a knot in the renal pelvis of the kidney.They attempted to pull out the stent percutaneously on (b)(6) 2015 but were unsuccessful.The complaint device currently remains inside of the patient's body.An additional procedure will occur at later date to remove the stent.

• Brand Name: KWART RETRO-INJECT 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 ; 8128294891
• MDR Report Key: 4685523
• MDR Text Key: 5676625
• Report Number: 1820334-2015-00199
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• 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
• Report Date: 03/12/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AQ-003600
• Device Lot 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
• Distributor Facility Aware Date: 01/12/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 04/09/2015
• 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
• Patient Age: 31 YR