MAUDE Adverse Event Report: HOLOGIC, INC. ATEC; VACUUM ASSISTED CORE BIOPSY DEVICE

Model Number	ATEC SAPPHIRE25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of today the investigation is in-progress and a follow up will be filed as needed.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 when the canister became full it resulted in back flow into the equipment tube rendering it unusable".A field engineer was dispatched to the site.
Event or Problem Description
"it was determined that blood had not gone past the filter and the vacuum assembly line was replaced.It is suspected that the lines were not connected to the canister the correct way.The customer was aware the patient had been on blood thinners, but was no longer using them at the time of the procedure and decided to continue.The full canister was noted at the end of the procedure so the procedure was not abandoned and no patient outcome since.".

• Brand Name: ATEC
• Common Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8565697
• Report Number: 1222780-2019-00100
• Device Sequence Number: 16717941
• 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): 04/10/2019

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
• Device Lot Number: 501354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other