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

Model Number	SMARK-EVIVA-13
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Internal reference #: (b)(4).
Event or Problem Description
It was reported that during the procedure the marker failed to deploy three times.All markers that failed were from the same lot.The procedure length was extended and therefore the patient remained under compression for longer than necessary.Biopsy was completed with no marker placed.No additional details available.

• 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: 8933002
• Report Number: 1222780-2019-00198
• Device Sequence Number: 19364986
• Product Code: NEU
• UDI-Device Identifier: 15420045503618
• UDI-Public: (01)15420045503618(10)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K062528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 01/08/2020
• Device Model Number: SMARK-EVIVA-13
• Device Catalogue Number: SMARK-EVIVA-13
• Device Lot Number: 19A08RD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1