MAUDE Adverse Event Report: HOLOGIC, INC. SECURMARK; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	SMARK-EVIVA-2S-13
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Two devices were used in this event which are reported under : 1222780-2021-00270.
Event or Problem Description
It was reported that on (b)(6) 2021 , during a breast biopsy procedure , the samples were taken and the secur mark for eviva , did not deploy.Images taken after the procedure did not show a clip in the breast cavity.No markers were placed in the breast.Patient was discharged without the markers and was not scheduled for another surgery to insert a new marker.No injury was reported to the patient.

• Brand Name: SECURMARK
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 12530919
• Report Number: 1222780-2021-00271
• Device Sequence Number: 3937545
• Product Code: NEU
• UDI-Device Identifier: 05420045503628
• UDI-Public: (01)05420045503628(17)220330(10)21C30RG
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2021

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: 03/30/2022
• Device Model Number: SMARK-EVIVA-2S-13
• Device Catalogue Number: SMARK-EVIVA-2S-13
• Device Lot Number: 21C30RG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1