MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Model Number	STLC-0004
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following a software upgrade, the needle options and parameters were not re-entered into the system.During a biopsy procedure the patient began bleeding during sampling after the needle penetrated an artery in the patient's breast.Pressure was applied to the breast to control the bleeding and the patient was evaluated by a doctor and breast surgeon on site and determined that no further medical intervention was required.The patient will need to return for a repeat biopsy.It was reported by the customer that the doctor did notice that their needle selection was not available in the system, but they continued with the biopsy.Following this event the site spoke with an applications specialist over the phone who walked them through entering their needle selections and parameters.A field engineer was dispatched to the site and evaluated the system.He found the system to be working as intended and the needle parameters to be correct after being loaded by the site staff.

• Brand Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
• Common Device Name: BIOPSY GUIDANCE SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 7399579
• Report Number: 1220984-2018-00093
• Device Sequence Number: 11067903
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: 15420045505858
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K122836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Radiologic Technologist
• Device Model Number: STLC-0004
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1