MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR¿; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number STAR1401

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  malfunction  

Event Description

Marker failed to deploy.No harm to the patient, another device used without issue.

• Brand Name: MAMMOSTAR¿
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road ste 2; saint paul MN 55110
• MDR Report Key: 9910284
• MDR Text Key: 185926883
• Report Number: 9910284
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STAR1401
• Device Catalogue Number: STAR1401
• Device Lot Number: 1908171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA