MAUDE Adverse Event Report: COOK INC FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS; KOE DILATOR, URETHRAL

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 ureteroscopy procedure on (b)(6) 2017.The attending physician indicated that the sheath came in contact with the patient.The pre-split tip on the flexor parallel ureteral access sheath and dilators did not separate as it was intended to.The obturator could not be removed therefore, the urologist had to remove the sheath and the wire guide completely and obtain a new sheath.The second sheath was opened and tested prior to making patient contact and exhibited the same difficulty with the tip.A third sheath was opened with no complications and the procedure was able to be completed as expected.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
Investigation/evaluation.Two opened flexor parallel ureteral access sheath and dilators were returned for investigation and analysis.Both dilators were returned in used condition.The split on both dilators was visible.A.038" teflon coated wire guide was used to wire both dilators.Following the instructions for use, retraction of the dilator from the sheath pulled the wire guide through the dilator split and confirmed the split was not obstructed.No manufacturing anomalies were evident on either of these devices.The reported device issue could not be confirmed.Dilator 1 - viewed under magnification had dried debris visible in the oval side port.Dilator 2 - a scrape was observed starting at the oval side port extending midway up the dilator tip.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of the device history record did not observe any non-conformances that may have contributed to this incident associated with complaint lot number 6126938.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 6126938.Based on the information provided and the results of our investigation the actual root cause is inconclusive.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• Brand Name: FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6394536
• Report Number: 1820334-2017-00367
• Device Sequence Number: 18995116
• Product Code: KOE
• UDI-Device Identifier: 00827002564305
• UDI-Public: (01)00827002564305(17)180817(10)6126938
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: FUS-095035-P
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1