MAUDE Adverse Event Report: COOK INC FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET; EYB CATHETER, URETERAL, GASTRO-UROLOGY

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the event is currently under investigation.
Event or Problem Description
It was reported during a ureteroscopy in the upper urinary tract the tip of the dual lumen catheter broke off into the kidney and had to be retrieved using graspers.No additional information was available at the time of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, quality control, specification and visual inspection of the returned device was conducted during the investigation.The device was returned for evaluation.A visual examination of the returned device showed the flexible tip was separated from the rest of the catheter.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the provided level of information, a definitive root cause cannot be determined or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• Brand Name: FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET
• Common Device Name: EYB CATHETER, URETERAL, GASTRO-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6098775
• Report Number: 1820334-2016-01295
• Device Sequence Number: 19113543
• Product Code: EYB
• UDI-Device Identifier: 00827002173231
• UDI-Public: (01)00827002173231(17)190714(10)7120714
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AQ-022610
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 68