MAUDE Adverse Event Report: HOLOGIC, INC. ATEC SAPPHIRE 25; BREAST BIOPSY SYSTEM

Model Number	ATEC SAPPHIRE25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a biopsy procedure using an atec unit, "the patient bled profusely and the blood loss filled the canister and traveled back up the tubing." it was reported that, "the patient had a hematoma and bled while they were doing the biopsy, which in turn filled the atec suros canister and tubing with blood." additional information indicated that the procedure was abandoned and has been rescheduled depending on the histology result.The hematoma was managed by the nursing team according to their directives "(i.E.Pressure dressing and ice pack etc.).A field engineer was dispatched to the site and replaced the filter and the system was working as intended.
Event or Problem Description
Additional information was received from the radiographer that the patient returned for a repeat successful biopsy and that the repaired system was working without issue.

• Brand Name: ATEC SAPPHIRE 25
• Common Device Name: BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8121742
• Report Number: 1222780-2018-00245
• Device Sequence Number: 11179960
• Product Code: KNW
• UDI-Device Identifier: 15420045504288
• UDI-Public: 15420045504288
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ATEC SAPPHIRE25
• Device Catalogue Number: ATEC SAPPHIRE25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATEC DISPOSABLE NEEDLE: LOT # UNKNOWN; ATEC DISPOSABLE NEEDLE: LOT # UNKNOWN
• Outcome Attributed to Adverse Event: Other