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

Model Number STAR1402

Device Problem Activation Problem (4042)

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

Event Date 07/02/2019

Event Type  malfunction  

Event Description

Md attempted to place clip at the biopsy site.The device failed to deploy.

• 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: 8788906
• MDR Text Key: 150980524
• Report Number: 8788906
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: STAR1402
• Device Catalogue Number: STAR1402
• 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: 07/10/2019
• Date Report to Manufacturer: 07/15/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA