MAUDE Adverse Event Report: COOK INC KOYLE DIAPER URETHRAL STENT; KOD CATHETER, UROLOGICAL

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	03/10/2017
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 a stent placement urethral procedure.The device in use was a koyle diaper urethral stent.It was reported that the stent inside the tube is snapping when the doctor is trying to move it.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
One koyle diaper urethral stent open package was received in used condition.The introducer protruded 6.Cm from the distal end of the stent and retracted into the proximal end 3cm.The stent and introducer length and inner/outer diameter dimensions were measured and found to be within design specifications.No manufacturing anomalies were observed with the stent or the introducer.During evaluation, the positioner was removed from the proximal end of the introducer.The introducer appeared stuck, it could not be pulled straight out of the stent.By twisting the stent and introducer in opposite directions the introducer was released from the stent.Friction between the two materials was noted.The introducer is bent 1cm from the proximal end.The likely root cause is product handling related; caused by another device.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 was performed.There were no non-conformances noted during the manufacturing process.A review of complaint history for this product and lot number combination found this is the only complaint that has been received.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: KOYLE DIAPER URETHRAL STENT
• Common Device Name: KOD CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6464655
• Report Number: 1820334-2017-00690
• Device Sequence Number: 477188
• Product Code: KOD
• UDI-Device Identifier: 00827002176683
• UDI-Public: (01)00827002176683(17)190601(10)7014984
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K820313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: KDSCFS-080050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1