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

Model Number	N/A
Medical Device Problem Code	Knotted (1340)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event evaluation: this historical complaint is being filed under 21 cfr part 803 as part of a retrospective review of complaint files.A review of complaint history and specifications was conducted during the investigation.The device, pictures, nor imaging were returned to assist with this investigation.The product in this case, a ufh-500-r multi-length ureteral stent, is manufactured in accordance with manufacturing instructions and inspected according to quality control specifications.The appropriate manufacturing controls are in place assuring functionality and device integrity prior to shipment.The lot record for the device, lot number: 5527558, was reviewed.No issues relating to product quality that may have contributed to this failure mode were observed.The product ifu in this case states: "individual variations of interaction between stents and urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested." based on the provided information, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
A cystoscopy, retrograde pyelogram, ureteroscopy, right eswl procedure was being performed on the (b)(6) male patient with a pre-existing condition of renal stone.The cystoscope was introduced and the right ureteral orifice was grasped and brought down.A portion came out and there was a slight hang up.Re-cystoscopy showed that there had been a loop caught as it coiled back on itself and the stent.With gradual traction, this easily released, came through the right ureteral orifice and was removed.The patient did not require and additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5653760
• Report Number: 1820334-2016-00386
• Device Sequence Number: 21047
• Product Code: FAD
• UDI-Device Identifier: 10827002499017
• UDI-Public: (01)10827002499017(17)171218(10)5527558
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-500-R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2015
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2015
• Initial Report FDA Received Date: 05/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR