MAUDE Adverse Event Report: COOK INCORPORATED PERFORMER; INTRODUCER, CATHETER

Model Number	G09691
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Sheath malfunction: it would not stay sealed and leaked.Malfunctioning sheath removed and replaced.No adverse patient outcome as a result of malfunction.

• Brand Name: PERFORMER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7062779
• Report Number: 7062779
• Device Sequence Number: 1235589
• Product Code: DYB
• UDI-Device Identifier: 00827002096912
• UDI-Public: (01)00827002096912(17)200828(10)8123615
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2017
• Report Date (Section F): 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/28/2020
• Device Model Number: G09691
• Device Catalogue Number: RCFW-16.0P-38-30-RB
• Device Lot Number: 8123615
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 86
• Date Report Sent to FDA: 11/20/2017