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

Model Number TRIMARK TD 3609

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

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 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
• Type of Device: BIOPSY SITE TISSUE MARKER DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 8855641
• MDR Text Key: 155556075
• Report Number: 1222780-2019-00176
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 15420045503304
• UDI-Public: (01)15420045503304(10)
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K023450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2018
• 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