MAUDE Adverse Event Report: COOK INCORPORATED NESTER; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	G47352
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device was damaged and not placed in patient.

• Brand Name: NESTER
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 18502132
• Report Number: 18502132
• Device Sequence Number: 20869627
• Product Code: KRD
• UDI-Device Identifier: 00827002473522
• UDI-Public: (01)00827002473522(17)241011(10)10044931
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2023
• Report Date (Section F): 09/06/2023

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: G47352
• Device Catalogue Number: MWCE-35-14-4-NESTER-01
• Device Lot Number: 10044931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 84 KG
• Date Report Sent to FDA: 09/06/2023