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

Model Number SMARK-EVIVA-2S-13

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

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 : 1222780-2021-00271.

Event 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
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 12530918
• MDR Text Key: 273442850
• Report Number: 1222780-2021-00270
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 05420045503628
• UDI-Public: (01)05420045503628(17)220330(10)21C30RG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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