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

Model Number	G43870
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of hypertension, type 2 diabetes, chronic heart failure and atrial fibrillation undergoing laparoscopic hand assisted left radical nephrectomy.While attempting to gain large bore venous access in the right ac space the needle was successfully placed but when the guide wire was threaded into the vein, there was resistance.When the wire was removed, it was frayed.No harm to patient.Per anesthesiologist - while attempting to gain large bore venous access in the right anterior chamber space using a micropuncture v access kit, the rigid needle was in a vein.When threading the guide wire into the vein, there was resistance.As the wire was pulled, it looked as if it was shearing.The entire assembly-wire plus needle out together.Dr and anesthesia tech discussed the incident and involved vascular services.Vascular services advised to continue on with surgery.Before case was completed, vascular surgeon came to view fluoroscopic images to confirm there were no fragments.

• Brand Name: MICROPUNCTURE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9774035
• Report Number: 9774035
• Device Sequence Number: 16747009
• Product Code: DYB
• UDI-Device Identifier: 00827002438705
• UDI-Public: (01)00827002438705(17)220826(10)9972043
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/25/2020
• Report Date (Section F): 02/25/2020

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: G43870
• Device Catalogue Number: MPIS-501-NT-SST
• Device Lot Number: 9972043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67
• Date Report Sent to FDA: 02/25/2020