MAUDE Adverse Event Report: HOLOGIC, INC EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM; VACUUM ASSISTED CORE BIOPSY DEVICE

Model Number	EVIVA_0913-12T
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.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 that during the biopsy, the breast tissue was dense and the calcifications moved away from the incoming needle.As a result the doctor decided to retarget and was able to fire the device three times.After sampling and lavage, it was difficult to remove the needle from the patient breast.Ultimately, the device was removed and the marker was then inserted.Marker insertion was "not as easy as usual," but the marker placement was successful and accurate.Removing the needle introducer sheeth was difficult and looked "knurled" when the device was removed from the breast.
Additional Manufacturer Narrative
Device received and visually inspected for reported complaint.The mating introducer was returned along with a marker inside of the sheathing.The reported complaint of a crumpled sheath was verified.This observation will be monitored and trended.

• Brand Name: EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM
• Common Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9166560
• Report Number: 1222780-2019-00232
• Device Sequence Number: 17114795
• Product Code: KNW
• UDI-Device Identifier: 25420045505336
• UDI-Public: (01)25420045505336(10)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 12/04/2020
• Device Model Number: EVIVA_0913-12T
• Device Catalogue Number: EVIVA_0913-12T
• Device Lot Number: 18M05R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2020
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1