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

Model Number TRIMARK 36-09

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).

Event Description

It was reported that when deploying the marker there was no marker in the biopsy cavity."we investigated the deployment device and nothing was found in side the device neither".No injury or misdiagnosis was reported.

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.

Manufacturer Narrative

The reported device was received, but could not be tested.Clinically used and latched device was returned and occluded with dried blood and the trap door was bent open.No marker was present in device window.The latched plunger rod could not be freed for testing due to dried blood.

• Brand Name: TRIMARK
• Type of Device: BIOPSY SITE TISSUE MARKER DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8460803
• MDR Text Key: 141359794
• Report Number: 1222780-2019-00067
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 15420045503304
• UDI-Public: 15420045503304
• Combination Product (y/n): N
• PMA/PMN Number: K023450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

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: 08/16/2020
• Device Model Number: TRIMARK 36-09
• Device Catalogue Number: TRIMARK 36-09
• Device Lot Number: 18H17RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 03/07/2019
• Supplement Dates FDA Received: 06/21/2019; 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1