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

Model Number STAR1401

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

Event Type  malfunction  

Event Description

Failure of the device to deploy clip at site of biopsy.Another product obtained, functioned as intended - no harm to the patient.This is a recurring problem with this device at this facility.The manufacturer has been notified and product has been returned.The problem persists.

• 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: 9864719
• MDR Text Key: 184450300
• Report Number: 9864719
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: STAR1401
• Device Catalogue Number: STAR1401
• Device Lot Number: 1908171A
• 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: 02/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA