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
(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
(b)(4).Investigation - evaluation: a review of complaint history, documentation, quality control, specifications, trends and a visual inspection of the returned device was conducted during the investigation.The visual examination reported the initial observations of the returned sheath noted the device was missing the stopcock.Dimensional verification confirmed device had been manufactured per material specification.Although attempts were made at recreating the event as described by the facility, the device was bio occluded in the valve body which would not allow for flushing.Destructive testing found the silicone disc to be scored properly, seated properly with no indication of excessive adhesive on the body threads.There is no evidence to suggest the product was not made to specifications.Detection activities are in place to prevent this failure mode from occurring in the field including a 100% leak test.An investigation is currently open and was previously initiated to investigate the root cause of this event.It was determined that while the health risks associated with this nonconformance can potentially range from low impact to moderate harm, it is unlikely that its occurrence will lead to a serious adverse health consequence to the patient.Based on all available market surveillance information, the likely severity associated with this failure mode is low impact.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
During a fistula gram 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: 5492268
• Report Number: 1820334-2016-00141
• Device Sequence Number: 19073442
• Product Code: DYB
• UDI-Device Identifier: 00827002134966
• UDI-Public: (01)00827002134966(17)181202(10)6421558
• 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: 2 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: 03/10/2016
• Supplement Report FDA Received Date: 09/14/2016
• 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: Other