MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age at time of event is currently unknown as information was not provided.Patient sex at tie of event is currently unknown as information was not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
During a fistulagram procedure, the valves on the device leaked.The patient did not require a blood transfusion and the physician was able to complete the procedure with this device.No harm to the patient and no additional procedures or intervention was required due to this occurrence.
Additional Manufacturer Narrative
Investigation/evaluation: during the course of the investigation, a review of the complaint history, documentation, specifications, and trends of the product was conducted.Initial observations of the returned sheath noted the device was missing the stopcock.Dimensional verification confirmed the device had been manufactured per material specification.By occluding the device with hemostats, functional testing confirmed leaking up and around the silicone disc in the valve assembly.Destructive testing found excessive adhesive on the check flow valve body which prevented firm seating of the silicone disc allowing for a leak path.It was unlikely that the occurrence would lead to a serious adverse health consequence to the patient.We will continue to monitor for similar complaints.
Event or Problem Description
During a fistulagram procedure, the valves on the device leaked.The patient did not require a blood transfusion and the physician was able to complete the procedure with this device.No harm to the patient and no additional procedures or intervention was required due to this occurrence.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5489577
• Report Number: 1820334-2016-00143
• Device Sequence Number: 13521059
• Product Code: DYB
• UDI-Device Identifier: 00827002134966
• UDI-Public: (01)00827002134966(17)180821(10)6142352
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/17/2016

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: RYCFW-7.0-35-6-CW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2016
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1