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

Model Number	G08024
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported during an unspecified procedure, after access was gained from the right femoral artery, the user felt "some uncorfortable feeling" when advancing the introducer over the wire guide.Upon removing the introducer from the patient's body, the tip of the sheath was confirmed to be frayed.As a result, another device was used to complete the procedure.No adverse effect to the patient reported.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6935921
• Report Number: 1820334-2017-03352
• Device Sequence Number: 11040752
• Product Code: DYB
• UDI-Device Identifier: 00827002080249
• UDI-Public: (01)00827002080249(17)180326(10)5632423
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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: G08024
• Device Catalogue Number: RCF-14.0-38-J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1