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 01/03/2019

Event Type  malfunction  

Event Description

A patient underwent ultrasound core biopsy, l breast.After biopsies were obtained, radiologist attempted to place clip in area but clip would not deploy.Procedure was completed without placement of breast clip.Manufacturer response for mammotome, mammotome mammostar biopsy site identifier (per site reporter).Equipment failure reported to debacore customer service.No product to return.

• 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: 8415998
• MDR Text Key: 138657300
• Report Number: 8415998
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2019,02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STAR1402
• Device Catalogue Number: STAR1402
• Device Lot Number: 1809205A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Weight: 71