MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT

Model Number	EVIVA_0913-12T
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Syncope/Fainting (4411)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported on (b)(6) 2021 that during a biopsy procedure a second device needed to be used to complete the biopsy.Additional information was received on 05/25/2021 that reported the initial device failed to suction tissue/cores and no samples were retrieved.The patient experienced "copious bleeding and ultimately fainting." attempts to obtain additional information on the patient impact have been unsuccessful as of today.
Event or Problem Description
Additional information on the patient impact was received on 06/29/2021.The customer reported that the bleeding was mentioned because it "contributed to the complexity of the case." the patient was not on any medication, such as blood thinners, that could affect blood fluidity.It was known before the procedure that the patient is a "fainter" and no medical intervention was required due to the reported issues.

• Brand Name: EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 12034522
• Report Number: 1222780-2021-00163
• Device Sequence Number: 4403785
• Product Code: KNW
• UDI-Device Identifier: 15420045505339
• UDI-Public: (01)15420045505339(17)210721(10)19G22RL
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K180233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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 Expiration Date: 07/21/2021
• Device Model Number: EVIVA_0913-12T
• Device Catalogue Number: EVIVA_0913-12T
• Device Lot Number: 19G22RL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1