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	06/18/2015
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, device history record, documentation, drawings, manufacturing instructions, quality control, specifications and a visual inspection of the returned device were conducted during the investigation.One universa firm ureteral stent set (stent only) was returned for investigation.Examination of the returned device observed: a severe kink at the base of the coil on the proximal end.The device does have the appearance of possibly being knotted and released by the apparent kink.The base of the distal coil appeared flattened slightly.The product in this case, a (b)(4) multi-length ureteral stent, is manufactured in accordance with manufacturing instructions and inspected according to quality control specification.The appropriate manufacturing controls are in place assuring functionality and device integrity prior to shipment.Lot record for the device, lot number: 5757530, 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.We will continue to monitor for similar complaints.
Event or Problem Description
A cystoscopy, retrograde pyelogram, ureteroscopy, stone removal, stent exchange procedure was being performed on the (b)(6) year old male patient.A knot was visualized at the proximal end of the stent in kidney via ureteroscopy.The knot was able to be straightened out and guided out using the ureteroscope.The procedure was completed without further incident.The patient did not require any 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: 5653717
• Report Number: 1820334-2016-00385
• Device Sequence Number: 20395
• Product Code: FAD
• UDI-Device Identifier: 10827002499017
• UDI-Public: (01)10827002499017(17)180330(10)5757530
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2015
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/23/2015
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 05/13/2016
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR