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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
It was reported by the user facility that a patient underwent an ureteroecopy with laser lithrotipsy procedure.The device in use was the universal soft ureteral stent set.The attending physician indicated that the stent buckled during insertion and the stent tore when they tried to remove the tether.The physician stated a new device was opened and used to complete the procedure.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
The investigation included a review of complaint history, device history record, documentation, specifications, and a visual inspection of the returned device.One universa soft ureteral stent set was received including one label; rpn ush-624-r, lot number 7597736, a stent, and a positioner.The stent was returned with the tether inside.The stent was torn on the proximal coil starting at the first side port.The tear stops at 2mm from the end of the coil.The tether was noted to be knotted in a second location 4.5cm above the manufactured knot.Both the positioner and stent were wired for occlusions using a wire guide.An unidentified liquid was observed inside the stent.The positioner had no manufacturing anomalies.Unable to recreate the reported "buckling" due to the stent being torn.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances identified during the manufacturing process.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received against the device lot number 7597736.Based on the evidence presented by the sample and the physical analysis, this stent was damaged during use.A definitive root cause was not determined and no conclusion can be drawn.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6445506
• Report Number: 1820334-2017-00526
• Device Sequence Number: 621812
• Product Code: FAD
• UDI-Device Identifier: 10827002499734
• UDI-Public: (01)10827002499734(17)200117(10)7597736
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: USH-624-R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1