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	01/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Event is still under investigation at this time.
Event or Problem Description
After the device was inserted, it was confirmed that blood was leaking from the valve.A new replacement device was used to complete the procedure.No additional information has been provided regarding patient outcome.
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation - a review of functional test, complaint history, instructions for use (ifu), quality control (qc) and a visual inspection was conducted during the investigation.The returned device was functionally tested by injecting water through the sidearm.No leakage was seen when flushed without occlusion of the sheath.The sheath was then clamped off and water was injected by hand with considerable pressure causing water to spray from the valve.The cap of the valve was cut off and the disc inspected.The slit in the valve was torn and jagged.It is likely that excessive side force on the dilator caused the disc to tear resulting in leakage.Valves are checked for proper check-flo valve assembly and leak tested during final inspection.This product is shipped with an ifu which states the intended use, contraindications, warning, precautions and instructions for use.The appropriate internal personnel have been notified, and we will continue to monitor for similar complaints.
Event or Problem Description
After the device was inserted, it was confirmed that blood was leaking from the valve.A new replacement device was used to complete the procedure.No additional information has been provided regarding patient outcome.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5447963
• Report Number: 1820334-2016-00078
• Device Sequence Number: 13540821
• Product Code: DYB
• UDI-Device Identifier: 00827002106260
• UDI-Public: (01)00827002106260(17)170401(10)4907908
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2016

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: RCFW-18.0P-38-40-RB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/29/2016
• Device Age: 21 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2016
• Supplement Report FDA Received Date: 06/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR