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

Model Number	SMARK-EVIVA-13
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review conducted: the device was released meeting all qa specifications.Device evaluated by mfr: 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.
Event or Problem Description
It was reported that a patient underwent biopsy procedure on (b)(6) 2022.The biopsy was successfully completed, and the marker (s-mark eviva was deployed via an introducer in the breast.However, when images were checked, no marker was visible.Introducer and site marker were then removed from the breast.It was found that the site marker had visibly perforated the introducer.As decided by the radiologist, no second marker was not deployed, because the introducer was removed from the site.As reported, there was no patient injury/harm, but the patient was left without the biopsy marker in the breast.The patient will not return for another marker insertion.

• Brand Name: SECURMARK
• Common Device Name: 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 20102 ; CR 20102
• MDR Report Key: 15255786
• Report Number: 1222780-2022-00219
• Device Sequence Number: 6687766
• Product Code: NEU
• UDI-Device Identifier: 05420045503611
• UDI-Public: (01)05420045503611(17)230428(10)22D28RB
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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 Model Number: SMARK-EVIVA-13
• Device Catalogue Number: SMARK-EVIVA-13
• Device Lot Number: 22D28RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female