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

Catalog Number STAR 1402

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Event Description

The device would not deploy as intended for procedure.A new device was obtained.There was no harm to the patient.

• Brand Name: MAMMOSTAR
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond rd ste 2; saint paul MN 55110
• MDR Report Key: 8939600
• MDR Text Key: 155812888
• Report Number: 8939600
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: STAR 1402
• Device Lot Number: 1903078A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA