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

Model Number	TRIMARK TD 3609
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
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.Internal reference #: (b)(4).
Event or Problem Description
It was reported that after deploying the marker, there was no clip seen on post biopsy images.The marker could not be found anywhere.It is assumed that there was no marker inside the device.No patient injury reported.

• Brand Name: TRIMARK
• Common Device Name: BIOPSY SITE TISSUE MARKER DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8855641
• Report Number: 1222780-2019-00176
• Device Sequence Number: 11380225
• Product Code: NEU
• UDI-Device Identifier: 15420045503304
• UDI-Public: (01)15420045503304(10)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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: 05/03/2020
• Device Model Number: TRIMARK TD 3609
• Device Catalogue Number: TRIMARK TD 3609
• Device Lot Number: 18E04RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1