MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	G02089
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The femoral arterial line was placed.The physician was suturing the line to anchor it to the skin when the catheter broke at the hub and the distal aspect of the line remained in the femoral artery, no longer attached to the hub.It remained in the body.Vascular surgery was consulted.The patient was not stable to transfer to the operating room for removal.Plan was to remove when the patient stabilized or if limb endangerment occurred device ultimately remained as foreign body in pt.No autopsy.

• Brand Name: COOK
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10095896
• Report Number: 10095896
• Device Sequence Number: 3386836
• Product Code: DQO
• UDI-Device Identifier: 00827002020894
• UDI-Public: (01)00827002020894(17)230217(10)10333348
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2020
• Report Date (Section F): 05/11/2020

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: G02089
• Device Catalogue Number: C-PMS-401J-FA
• Device Lot Number: 10333348
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/11/2020