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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported that during an aortic graft procedure, the valve membrane was chipped.The valve membrane was chipped out of the performer introducer.The patient was unharmed.When the device was returned for investigation the additional failure mode of hub separation was noted.No additional details have been received.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.A performer introducer sheath and dilator were returned for investigation.The dilator was returned with clear tape affixed to the shaft.The sheath was returned with the check-flo assembly separated from the shaft of the sheath, and the silicone disc was separated from the check-flo assembly.A kink was observed in the sheath tubing 23.5 cm from the distal end, and the flare of the sheath had a ruffled appearance.Visual inspection of the silicone disc found a small tear in the webbing and an indentation in one quadrant of the disc.The disc appeared to be scored correctly.A dilator was able to be advanced through the center of the silicone disc.The inner diameter of the check-flo cap, connector cap, and check-flo body were measured and all of the components were found to be manufactured to specification.There is no evidence to suggest the product was not made to specifications.Review of the device history record 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, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.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: 6421545
• Report Number: 1820334-2017-00573
• Device Sequence Number: 550978
• Product Code: DYB
• UDI-Device Identifier: 00827002284388
• UDI-Public: (01)00827002284388(17)170501(10)4945965
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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: RCFW-14.0-38-45-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1