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	08/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A performer introducer was used in a fistulogram procedure in the arm.It was reported that, when trying to advance the guide wire through the valve, the valve was leaking.The physician replaced the sheath and completed the procedure without issue.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
A voluntary medwatch report ((b)(4)) was received on 25sep2017 and stated, "sheath inserted to access dialysis fistula, when wire inserted, valve leaked.Original intended procedure: ultra-sound guided antegrade cannulation of left cephalic vein".Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, visual inspection and functional testing of the returned device was conducted during the investigation.The sheath and dilator of the performer introducer were returned.No wire guide was returned for examination.A kink is noted 4mm from the proximal hub.The sheath was tested for leakage.No leakage was detected.A 0.035" wire guide was inserted into the sheath.Slight leakage was detected from the valve around the wire guide.The connector cap was disassembled from the check-flo body.The check-flo cap was disassembled from the body.A small amount of glue was visible around the threads of the check-flo body.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; the root cause for the failure of leakage has been identified as inadequate tightening of the cap onto the valve body.Measures have been initiated to address this failure mode.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6842737
• Report Number: 1820334-2017-02768
• Device Sequence Number: 125349
• Product Code: DYB
• UDI-Device Identifier: 00827002106758
• UDI-Public: (01)00827002106758(17)200517(10)7919477
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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: RYCFW-6.0-35-6-RB-CW
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR