MAUDE Adverse Event Report: HOLOGIC, INC., HEADQUARTERS HOLOGIC; ATEC

Model Number	SAPPHIRE
Medical Device Problem Codes	Decrease in Suction (1146); Suction Problem (2170); Device Operational Issue (2914)
Health Effect - Clinical Codes	Syncope (1610); Hematoma (1884)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a stereotactic breast biopsy, the hologic atec vacuum assist machine did not function properly.This unit did not have the proper amount of suction and we were unable to get the proper amount of tissue resulting in a repeat biopsy for this pt.The pt went to er later that evening due to syncope.The pt developed a large 10 cm hematoma and her hemoglobin had dropped from the blood pooling in her breast.We did get this vac assist unit replaced with a replacement from hologic.When we went to do another stereotactic biopsy on a different pt, this replacement vac assist unit also lacked suction and this pt also had to have a repeat biopsy.Hologic clinical educator came in and suggested sending this unit back for another replacement.The second pt has not had any issues that we are aware of at this time.

• Brand Name: HOLOGIC
• Common Device Name: ATEC
• Manufacturer (Section D): HOLOGIC, INC., HEADQUARTERS; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7677107
• Report Number: 7677107
• Device Sequence Number: 12632985
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2018
• Report Date (Section F): 06/21/2018

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: Health Professional
• Device Model Number: SAPPHIRE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Distributor Facility Aware Date: 06/11/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 72