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

Model Number EVIVA_0913-20

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that during the breast biopsy procedure, when the needle fired it "bounced" inside the patient breast.It was noted that the clip on the stage of the needle was not sturdy and it was loosely attached.They attempted to move forward with the biopsy, but were not getting any suction.The technologist noticed there was a large kink in the tubing.The technologist does not recall anything happening during set up that would have caused this.The needle was taken out of the breast and a new needle was opened.The biopsy was successfully completed with the new needle.Additional x-ray exposures were required to complete the procedure.

• Brand Name: EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM
• Type of Device: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 9195261
• MDR Text Key: 162674290
• Report Number: 1222780-2019-00236
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 25420045504971
• UDI-Public: (01)25420045504971(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2021
• Device Model Number: EVIVA_0913-20
• Device Catalogue Number: EVIVA_0913-20
• Device Lot Number: 19F17RL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1