MAUDE Adverse Event Report: HOLOGIC, INC SECURMARK; BIOPSY SITE TISSUE MARKER DEVICE

Model Number	SMARK-CELERO-2S
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the patient had a double breast biopsy for two different breast masses.Markers were placed successfully.Upon completion of the post biopsy mammogram to ensure the correct placement of the markers, it was noted that one marker was actually an x shaped marker and not a top hat marker that the packaging stated.The patient was not injured or misdiagnosed as a result of this.Additional information from the facility states "it might have been an issue with multiple markers in patient and nothing is wrong with hologic devices.".

• Brand Name: SECURMARK
• Common Device Name: BIOPSY SITE TISSUE MARKER DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9373172
• Report Number: 1222780-2019-00270
• Device Sequence Number: 14076062
• Product Code: NEU
• UDI-Device Identifier: 15420045503403
• UDI-Public: (01)15420045503403(10)
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K062528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2019

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: 03/12/2020
• Device Model Number: SMARK-CELERO-2S
• Device Catalogue Number: SMARK-CELERO-2S
• Device Lot Number: 19C13RC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1