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

Model Number G08308

Device Problems Complete Blockage (1094); Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2021

Event Type  malfunction  

Event Description

6 fr sheath with end hole blocked with plastic.Technologist unable to thread wire in end of sheath.

• Brand Name: PERFORMER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12786340
• MDR Text Key: 280582180
• Report Number: 12786340
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G08308
• Device Catalogue Number: RCFW-6.0-38-63-RB-MTS
• Device Lot Number: 13499440
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3285 DA
• Patient Sex: Female